Trial Outcomes & Findings for Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Rectal Cancer (NCT NCT00726622)

NCT ID: NCT00726622

Last Updated: 2020-05-07

Results Overview

The primary endpoint will be a composite endpoint of oncologic factors which are indicative of an adequate surgical resection based on pathologic evaluation. Primary endpoint parameters: * Circumferential margin \> 1 mm * Negative distal margin * Completeness of total mesorectal excision (TME) A complete TME is a rectal resection specimen that has an intact mesorectum and covering peritoneal envelope all the way to the level of rectal transection with no coning in of the mesorectum above the point of transection. The surface of the peritoneal covering should be smooth and shiny with no defects exposing the underlying fat. All three criteria must be met for a resection to be deemed adequate. Laparoscopic-assisted resection will be compared to Open rectal resection to determine if it is non-inferior.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 486 participants
• Primary outcome timeframe: At time of Surgery
• Results posted on: 2020-05-07

Participant Flow

Participant milestones

Measure	Arm 1: Open Laparotomy and Rectal Resection Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.	Arm 2: Laparoscopic-assisted Rectal Resection Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
Overall Study STARTED	243	243
Overall Study COMPLETED	225	240
Overall Study NOT COMPLETED	18	3

Reasons for withdrawal

Measure	Arm 1: Open Laparotomy and Rectal Resection Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.	Arm 2: Laparoscopic-assisted Rectal Resection Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
Overall Study Withdrawal by Subject	16	2
Overall Study Physician Decision	0	1
Overall Study Metastasis	2	0

Baseline Characteristics

Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Rectal Cancer

Baseline characteristics by cohort

Measure	Arm 1: Open Laparotomy and Rectal Resection n=239 Participants Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.	Arm 2: Laparoscopic-assisted Rectal Resection n=242 Participants Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.	Total n=481 Participants Total of all reporting groups
Age, Continuous	57.2 years STANDARD_DEVIATION 12.1 • n=93 Participants	57.7 years STANDARD_DEVIATION 11.5 • n=4 Participants	57.4 years STANDARD_DEVIATION 11.8 • n=27 Participants
Sex: Female, Male Female	81 Participants n=93 Participants	86 Participants n=4 Participants	167 Participants n=27 Participants
Sex: Female, Male Male	158 Participants n=93 Participants	156 Participants n=4 Participants	314 Participants n=27 Participants
Region of Enrollment United States	239 participants n=93 Participants	242 participants n=4 Participants	481 participants n=27 Participants

PRIMARY outcome

Timeframe: At time of Surgery

Population: Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.

The primary endpoint will be a composite endpoint of oncologic factors which are indicative of an adequate surgical resection based on pathologic evaluation.

Primary endpoint parameters:

• Circumferential margin > 1 mm
• Negative distal margin
• Completeness of total mesorectal excision (TME) A complete TME is a rectal resection specimen that has an intact mesorectum and covering peritoneal envelope all the way to the level of rectal transection with no coning in of the mesorectum above the point of transection. The surface of the peritoneal covering should be smooth and shiny with no defects exposing the underlying fat.

All three criteria must be met for a resection to be deemed adequate. Laparoscopic-assisted resection will be compared to Open rectal resection to determine if it is non-inferior.

Outcome measures

Measure	Arm 1: Open Laparotomy and Rectal Resection n=222 Participants Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.	Arm 2: Laparoscopic-assisted Rectal Resection n=240 Participants Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
Comparing Laparoscopic-assisted Resection to Open Rectal Resection for Rectal Cancer as Measured by the Percentage of Patients With Successful Resection Based on Pathological Evaluation.	86.9 percentage of participants Interval 82.5 to 91.4	81.7 percentage of participants Interval 76.5 to 86.9

SECONDARY outcome

Timeframe: At time of surgery

Population: Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.

Complete total mesorectal excision was defined as a rectal resection specimen having smooth surface of mesorectal fascia with all fat contained in the enveloping fascia to a level 5 cm below the tumor for tumor-specific total mesorectal excision for upper rectal cancer, or the entire mesorectal envelope present for low rectal cancer. Nearly complete was defined as a rectal resection specimen having the mesorectal envelope intact except for defects no more than 5 mm deep, with no loss of mesorectal fat.

The percentage of patients with complete or nearly complete mesorectal excision was calculated along with the binomial 95% CI.

Outcome measures

Measure	Arm 1: Open Laparotomy and Rectal Resection n=222 Participants Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.	Arm 2: Laparoscopic-assisted Rectal Resection n=240 Participants Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
Completeness of Total Mesorectal Excision (Complete or Nearly Complete)	95.1 percentage of participants Interval 92.2 to 97.9	92.1 percentage of participants Interval 88.7 to 95.5

SECONDARY outcome

Timeframe: At time of surgery

Population: Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.

The percentage of patients with negative distal margin (>1 mm between the closest tumor to the cut edge of the tissue) was calculated along with binomial 95% confidence intervals.

Outcome measures

Measure	Arm 1: Open Laparotomy and Rectal Resection n=222 Participants Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.	Arm 2: Laparoscopic-assisted Rectal Resection n=240 Participants Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
Negative Distal Resected Margin	98.2 percentage of participants Interval 96.5 to 99.95	98.3 percentage of participants Interval 96.7 to 99.95

SECONDARY outcome

Timeframe: At time of surgery

Population: Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.

The distance between the closest tumor to the cut edge of the tissue was measure post-resection. The percentage of patients with >1mm between the closest tumor to the cut edge of the tissue was calculated with a binomial 95% confidence interval.

Outcome measures

Measure	Arm 1: Open Laparotomy and Rectal Resection n=222 Participants Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.	Arm 2: Laparoscopic-assisted Rectal Resection n=240 Participants Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
Circumferential Margin > 1 mm	92.3 percentage of participants Interval 88.8 to 95.8	87.9 percentage of participants Interval 83.8 to 92.0

SECONDARY outcome

Timeframe: Two weeks post-surgery

Population: Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.

The mean number of days required post-surgery to the when the patient was released from the hospital was calculated.

Outcome measures

Measure	Arm 1: Open Laparotomy and Rectal Resection n=222 Participants Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.	Arm 2: Laparoscopic-assisted Rectal Resection n=240 Participants Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
Length of Stay	7.0 days Standard Deviation 3.4	7.3 days Standard Deviation 5.4

SECONDARY outcome

Timeframe: Two weeks post-surgery

Population: Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.

The number of days patients received parenteral narcotics post-surgery were counted.

Outcome measures

Measure	Arm 1: Open Laparotomy and Rectal Resection n=222 Participants Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.	Arm 2: Laparoscopic-assisted Rectal Resection n=240 Participants Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
Use of Pain Medication	4.2 days Standard Deviation 2.8	4.2 days Standard Deviation 3.9

SECONDARY outcome

Timeframe: During surgery

Population: Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.

Open to close operative time.

Outcome measures

Measure	Arm 1: Open Laparotomy and Rectal Resection n=222 Participants Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.	Arm 2: Laparoscopic-assisted Rectal Resection n=240 Participants Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
Operative Times	220.6 minutes Standard Deviation 92.4	266.2 minutes Standard Deviation 101.9

SECONDARY outcome

Timeframe: Up to 2 years post surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years post surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years post surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years post surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years post surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years post surgery

Outcome measures

Outcome data not reported

Adverse Events

Arm 1: Open Laparotomy and Rectal Resection

Serious events: 11 serious events

Other events: 201 other events

Deaths: 0 deaths

Arm 2: Laparoscopic-assisted Rectal Resection

Serious events: 10 serious events

Other events: 207 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm 1: Open Laparotomy and Rectal Resection n=239 participants at risk Open laparotomy and rectal resection: Patients undergo open laparotomy and rectal resection.	Arm 2: Laparoscopic-assisted Rectal Resection n=242 participants at risk Laparoscopic-assisted rectal resection: Patients undergo laparoscopic-assisted rectal resection.
Blood and lymphatic system disorders Hemoglobin decreased	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Cardiac disorders Arrhythmia supraventricular	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Cardiac disorders Atrial fibrillation	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Cardiac disorders Atrial flutter	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Cardiac disorders Cardiac valve disease	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Cardiac disorders Left ventricular dysfunction	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Cardiac disorders Myocardial ischemia	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Cardiac disorders Pericardial effusion	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Cardiac disorders Sinus tachycardia	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Cardiac disorders Ventricular tachycardia	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Abdominal distension	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Abdominal pain	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Diarrhea	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Fecal incontinence	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Ileus	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Nausea	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Rectal fistula	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Rectal pain	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Small intestinal obstruction	0.84% 2/239 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Vomiting	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
General disorders Edema limbs	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
General disorders Fatigue	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
General disorders Fever	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
General disorders Multi-organ failure	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
General disorders Pain	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Abdominal infection	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Infection	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Pelvic infection	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Sepsis	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Urinary tract infection	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Injury, poisoning and procedural complications Intraoperative complications	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Injury, poisoning and procedural complications Intraoperative gastrointestinal injury - Pancreas	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Investigations Cardiac troponin T increased	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Investigations Creatine phosphokinase increased	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Investigations Creatinine increased	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Investigations INR increased	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Investigations Laboratory test abnormal	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Investigations Platelet count decreased	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Investigations Weight loss	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Acidosis	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Blood glucose increased	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Dehydration	0.84% 2/239 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Serum albumin decreased	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Serum calcium decreased	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Serum magnesium decreased	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Serum magnesium increased	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Serum phosphate decreased	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Serum potassium decreased	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Serum potassium increased	0.84% 2/239 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Serum sodium decreased	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Serum triglycerides increased	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Musculoskeletal and connective tissue disorders Back pain	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Musculoskeletal and connective tissue disorders Buttock pain	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Musculoskeletal and connective tissue disorders Muscle weakness	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Nervous system disorders Neurological disorder NOS	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Psychiatric disorders Anxiety	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Psychiatric disorders Confusion	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Psychiatric disorders Depression	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Renal and urinary disorders Glomerular filtration rate decreased	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Renal and urinary disorders Renal failure	1.3% 3/239 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Renal and urinary disorders Urinary retention	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Renal and urinary disorders Urogenital disorder	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Reproductive system and breast disorders Erectile dysfunction	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Reproductive system and breast disorders Perineal pain	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Vascular disorders Hypertension	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Vascular disorders Hypotension	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Vascular disorders Thrombosis	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.

Other adverse events

Measure	Arm 1: Open Laparotomy and Rectal Resection n=239 participants at risk Open laparotomy and rectal resection: Patients undergo open laparotomy and rectal resection.	Arm 2: Laparoscopic-assisted Rectal Resection n=242 participants at risk Laparoscopic-assisted rectal resection: Patients undergo laparoscopic-assisted rectal resection.
Renal and urinary disorders Bladder hemorrhage	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Renal and urinary disorders Bladder spasm	0.84% 2/239 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Renal and urinary disorders Glomerular filtration rate decreased	0.84% 2/239 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Renal and urinary disorders Hemoglobin urine positive	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Renal and urinary disorders Hemorrhage urinary tract	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Renal and urinary disorders Renal failure	2.9% 7/239 • Number of events 7 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.1% 5/242 • Number of events 5 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Renal and urinary disorders Ureteric obstruction	1.3% 3/239 • Number of events 5 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Renal and urinary disorders Ureteric stenosis	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Renal and urinary disorders Urethral obstruction	0.42% 1/239 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Renal and urinary disorders Urethral pain	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Renal and urinary disorders Urinary frequency	2.9% 7/239 • Number of events 8 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.9% 7/242 • Number of events 12 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Renal and urinary disorders Urinary incontinence	1.7% 4/239 • Number of events 8 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.5% 6/242 • Number of events 6 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Renal and urinary disorders Urinary retention	10.9% 26/239 • Number of events 43 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	16.5% 40/242 • Number of events 54 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Renal and urinary disorders Urine discoloration	0.84% 2/239 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Renal and urinary disorders Urogenital disorder	3.3% 8/239 • Number of events 11 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.7% 4/242 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Renal and urinary disorders Vesical fistula	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Blood and lymphatic system disorders Blood disorder	1.3% 3/239 • Number of events 13 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.2% 3/242 • Number of events 6 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Blood and lymphatic system disorders Febrile neutropenia	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Blood and lymphatic system disorders Hemoglobin decreased	13.8% 33/239 • Number of events 51 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	12.8% 31/242 • Number of events 46 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Blood and lymphatic system disorders Hemolysis	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Blood and lymphatic system disorders Lymphatic disorder	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Blood and lymphatic system disorders Thrombotic microangiopathy	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Cardiac disorders Arrhythmia	2.1% 5/239 • Number of events 9 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.1% 5/242 • Number of events 5 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Cardiac disorders Atrial fibrillation	1.7% 4/239 • Number of events 5 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Cardiac disorders Cardiac disorder	0.84% 2/239 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Cardiac disorders Cardiac pain	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Cardiac disorders Left ventricular dysfunction	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Cardiac disorders Myocardial ischemia	1.7% 4/239 • Number of events 5 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.7% 4/242 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Cardiac disorders Pericardial effusion	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Cardiac disorders Restrictive cardiomyopathy	0.42% 1/239 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Cardiac disorders Sinus bradycardia	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Cardiac disorders Sinus tachycardia	2.9% 7/239 • Number of events 7 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	3.3% 8/242 • Number of events 8 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Cardiac disorders Ventricular arrhythmia	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Cardiac disorders Ventricular tachycardia	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.7% 4/242 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Ear and labyrinth disorders Tinnitus	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Endocrine disorders Endocrine disorder	0.84% 2/239 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Eye disorders Extraocular muscle paresis	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Eye disorders Vision blurred	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Eye disorders Watering eyes	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Abdominal distension	5.9% 14/239 • Number of events 19 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	5.0% 12/242 • Number of events 16 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Abdominal pain	13.4% 32/239 • Number of events 57 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	18.6% 45/242 • Number of events 72 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Anal hemorrhage	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.2% 3/242 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Anal pain	1.7% 4/239 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.1% 5/242 • Number of events 7 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Ascites	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Cecal obstruction	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Colitis	0.84% 2/239 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Constipation	7.5% 18/239 • Number of events 23 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	7.4% 18/242 • Number of events 20 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Diarrhea	18.0% 43/239 • Number of events 87 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	18.2% 44/242 • Number of events 74 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Dry mouth	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Dyspepsia	1.7% 4/239 • Number of events 5 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Dysphagia	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.2% 3/242 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Ear, nose and throat examination abnormal	1.7% 4/239 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Enteritis	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Esophageal varices hemorrhage	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Esophagitis	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Fecal incontinence	26.8% 64/239 • Number of events 117 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	21.9% 53/242 • Number of events 101 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Flatulence	2.5% 6/239 • Number of events 6 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.1% 5/242 • Number of events 7 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Gastritis	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Gastrointestinal disorder	10.0% 24/239 • Number of events 37 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	12.8% 31/242 • Number of events 43 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Gastrointestinal fistula	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Hemorrhoids	2.1% 5/239 • Number of events 7 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Ileal hemorrhage	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Ileus	16.3% 39/239 • Number of events 47 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	14.5% 35/242 • Number of events 40 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Intra-abdominal hemorrhage	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Mucositis oral	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Nausea	18.0% 43/239 • Number of events 70 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	22.3% 54/242 • Number of events 88 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Oral hemorrhage	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Oral pain	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Pancreatitis	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Proctitis	0.84% 2/239 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Proctoscopy abnormal	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Rectal fistula	6.7% 16/239 • Number of events 28 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	3.3% 8/242 • Number of events 12 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Rectal hemorrhage	2.1% 5/239 • Number of events 6 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	3.3% 8/242 • Number of events 8 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Rectal pain	33.1% 79/239 • Number of events 149 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	35.1% 85/242 • Number of events 153 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Rectal perforation	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Rectal stenosis	5.0% 12/239 • Number of events 21 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	5.8% 14/242 • Number of events 28 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Salivary gland disorder	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Small intestinal obstruction	10.0% 24/239 • Number of events 28 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	7.0% 17/242 • Number of events 19 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Stomach pain	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.2% 3/242 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.84% 2/239 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Gastrointestinal disorders Vomiting	9.2% 22/239 • Number of events 28 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	10.3% 25/242 • Number of events 36 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
General disorders Chest pain	2.5% 6/239 • Number of events 7 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.7% 4/242 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
General disorders Chills	1.7% 4/239 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.7% 4/242 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
General disorders Disease progression	0.84% 2/239 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
General disorders Edema limbs	4.2% 10/239 • Number of events 13 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	4.5% 11/242 • Number of events 12 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
General disorders Facial pain	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
General disorders Fatigue	20.5% 49/239 • Number of events 114 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	19.8% 48/242 • Number of events 73 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
General disorders Fever	7.9% 19/239 • Number of events 23 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	11.2% 27/242 • Number of events 34 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
General disorders Flu-like symptoms	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
General disorders Gait abnormal	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
General disorders General symptom	1.3% 3/239 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.7% 4/242 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
General disorders Localized edema	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.2% 3/242 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
General disorders Pain	8.4% 20/239 • Number of events 31 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	7.9% 19/242 • Number of events 27 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
General disorders Visceral edema	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Hepatobiliary disorders Cholecystitis	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Hepatobiliary disorders Hepatic failure	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Hepatobiliary disorders Hepatobiliary disease	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Immune system disorders Hypersensitivity	1.3% 3/239 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Immune system disorders Immune system disorder	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Abdominal infection	2.5% 6/239 • Number of events 7 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.2% 3/242 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Anal infection	1.3% 3/239 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Anorectal infection	2.1% 5/239 • Number of events 5 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Appendicitis perforated	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Bladder infection	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.7% 4/242 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Bronchitis	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Colitis, infectious (e.g., Clostridium difficile)	1.3% 3/239 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.7% 4/242 • Number of events 6 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Device related infection	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Eye infection	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Ileal infection	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Infection	5.4% 13/239 • Number of events 26 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	6.2% 15/242 • Number of events 23 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Infectious colitis	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Kidney infection	0.84% 2/239 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Lip infection	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Mucosal infection	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Nail infection	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Pelvic infection	2.1% 5/239 • Number of events 7 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.2% 3/242 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Peritoneal infection	1.3% 3/239 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Phlebitis infective	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Pneumonia	1.3% 3/239 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Scrotal infection	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Sepsis	2.5% 6/239 • Number of events 7 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.2% 3/242 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Sinusitis	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Skin infection	1.3% 3/239 • Number of events 5 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.1% 5/242 • Number of events 5 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Soft tissue infection	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Stoma site infection	0.84% 2/239 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Upper respiratory infection	0.84% 2/239 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Urinary tract infection	7.1% 17/239 • Number of events 21 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	6.6% 16/242 • Number of events 20 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Infections and infestations Wound infection	7.1% 17/239 • Number of events 23 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	7.0% 17/242 • Number of events 21 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Injury, poisoning and procedural complications Bruising	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Injury, poisoning and procedural complications Fracture	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.2% 3/242 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Injury, poisoning and procedural complications Gastrointestinal anastomotic leak	0.84% 2/239 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Injury, poisoning and procedural complications Intestinal stoma leak	1.3% 3/239 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Injury, poisoning and procedural complications Intestinal stoma obstruction	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Injury, poisoning and procedural complications Intestinal stoma site bleeding	2.5% 6/239 • Number of events 6 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.2% 3/242 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Injury, poisoning and procedural complications Intraoperative complications	8.8% 21/239 • Number of events 29 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	5.8% 14/242 • Number of events 28 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Injury, poisoning and procedural complications Intraoperative neurological injury - NERVES: CN IX (glossopharyngeal) motor pharynx	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Injury, poisoning and procedural complications Large intestinal anastomotic leak	0.84% 2/239 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.2% 3/242 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Injury, poisoning and procedural complications Postoperative hemorrhage	2.1% 5/239 • Number of events 5 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.1% 5/242 • Number of events 6 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Injury, poisoning and procedural complications Prolapse of intestinal stoma	2.1% 5/239 • Number of events 6 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.2% 3/242 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Injury, poisoning and procedural complications Rectal anastomotic leak	3.3% 8/239 • Number of events 11 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.1% 5/242 • Number of events 6 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Injury, poisoning and procedural complications Seroma	2.5% 6/239 • Number of events 6 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Injury, poisoning and procedural complications Small intestinal anastomotic leak	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Injury, poisoning and procedural complications Thermal burn	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Injury, poisoning and procedural complications Tracheostomy site bleeding	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Injury, poisoning and procedural complications Ureteric anastomotic leak	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Injury, poisoning and procedural complications Urethral anastomotic leak	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Injury, poisoning and procedural complications Urostomy leak	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Injury, poisoning and procedural complications Vascular access complication	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Injury, poisoning and procedural complications Wound dehiscence	10.9% 26/239 • Number of events 37 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	7.4% 18/242 • Number of events 34 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Investigations Alanine aminotransferase increased	1.7% 4/239 • Number of events 8 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.2% 3/242 • Number of events 6 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Investigations Alkaline phosphatase increased	1.7% 4/239 • Number of events 9 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Investigations Aspartate aminotransferase increased	1.7% 4/239 • Number of events 7 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.7% 4/242 • Number of events 7 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Investigations Bilirubin increased	0.84% 2/239 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Investigations Cardiac troponin I increased	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Investigations Coagulopathy	0.84% 2/239 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.2% 3/242 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Investigations Creatine phosphokinase increased	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Investigations Creatinine increased	2.9% 7/239 • Number of events 8 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.9% 7/242 • Number of events 8 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Investigations INR increased	0.42% 1/239 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Investigations Laboratory test abnormal	3.8% 9/239 • Number of events 17 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.5% 6/242 • Number of events 10 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Investigations Leukocyte count decreased	2.1% 5/239 • Number of events 6 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	5.4% 13/242 • Number of events 18 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Investigations Lymphocyte count decreased	0.84% 2/239 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.5% 6/242 • Number of events 8 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Investigations Neutrophil count decreased	1.7% 4/239 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.9% 7/242 • Number of events 8 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Investigations Platelet count decreased	4.2% 10/239 • Number of events 15 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	3.7% 9/242 • Number of events 12 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Investigations Serum cholesterol increased	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Investigations Weight gain	0.84% 2/239 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Investigations Weight loss	6.7% 16/239 • Number of events 27 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	5.4% 13/242 • Number of events 21 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Acidosis	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Anorexia	9.2% 22/239 • Number of events 29 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	5.8% 14/242 • Number of events 20 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Blood bicarbonate decreased	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Blood glucose increased	4.6% 11/239 • Number of events 17 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	4.5% 11/242 • Number of events 23 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Dehydration	10.9% 26/239 • Number of events 32 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	5.8% 14/242 • Number of events 22 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Serum albumin decreased	3.3% 8/239 • Number of events 8 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.2% 3/242 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Serum calcium decreased	3.8% 9/239 • Number of events 10 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.1% 5/242 • Number of events 6 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Serum calcium increased	0.84% 2/239 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Serum magnesium decreased	2.5% 6/239 • Number of events 8 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Serum magnesium increased	0.84% 2/239 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Serum phosphate decreased	1.3% 3/239 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.1% 5/242 • Number of events 5 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Serum potassium decreased	5.9% 14/239 • Number of events 18 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	4.5% 11/242 • Number of events 13 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Serum potassium increased	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.1% 5/242 • Number of events 5 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Serum sodium decreased	3.3% 8/239 • Number of events 9 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.5% 6/242 • Number of events 6 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Serum sodium increased	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Metabolism and nutrition disorders Serum triglycerides increased	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Musculoskeletal and connective tissue disorders Arthritis	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.2% 3/242 • Number of events 5 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Musculoskeletal and connective tissue disorders Back pain	4.6% 11/239 • Number of events 23 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	3.3% 8/242 • Number of events 11 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Musculoskeletal and connective tissue disorders Buttock pain	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.2% 3/242 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Musculoskeletal and connective tissue disorders Chest wall pain	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Musculoskeletal and connective tissue disorders Joint pain	2.9% 7/239 • Number of events 9 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Musculoskeletal and connective tissue disorders Muscle weakness	2.1% 5/239 • Number of events 6 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	3.3% 8/242 • Number of events 10 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Musculoskeletal and connective tissue disorders Muscle weakness trunk	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	2.5% 6/239 • Number of events 10 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	3.3% 8/242 • Number of events 8 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Musculoskeletal and connective tissue disorders Myalgia	0.84% 2/239 • Number of events 7 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.1% 5/242 • Number of events 6 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Musculoskeletal and connective tissue disorders Pain in extremity	2.5% 6/239 • Number of events 9 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.9% 7/242 • Number of events 8 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Nervous system disorders Dizziness	4.2% 10/239 • Number of events 12 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	3.3% 8/242 • Number of events 9 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Nervous system disorders Encephalopathy	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Nervous system disorders Headache	1.3% 3/239 • Number of events 6 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	3.3% 8/242 • Number of events 9 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Nervous system disorders Ischemia cerebrovascular	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.2% 3/242 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Nervous system disorders Memory impairment	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Nervous system disorders Myelitis	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Nervous system disorders Nervous system disorders - Other, specify	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Nervous system disorders Neuralgia	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Nervous system disorders Neurological disorder NOS	1.7% 4/239 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.1% 5/242 • Number of events 10 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Nervous system disorders Peripheral motor neuropathy	0.42% 1/239 • Number of events 5 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.1% 5/242 • Number of events 7 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Nervous system disorders Peripheral sensory neuropathy	14.6% 35/239 • Number of events 72 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	16.1% 39/242 • Number of events 83 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Nervous system disorders Radiculitis brachial	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Nervous system disorders Seizure	0.84% 2/239 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Nervous system disorders Syncope	0.84% 2/239 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.2% 3/242 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Nervous system disorders Taste alteration	1.3% 3/239 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Psychiatric disorders Agitation	0.84% 2/239 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Psychiatric disorders Anxiety	3.3% 8/239 • Number of events 11 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.7% 4/242 • Number of events 12 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Psychiatric disorders Confusion	1.7% 4/239 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.7% 4/242 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Psychiatric disorders Depression	4.2% 10/239 • Number of events 26 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	6.6% 16/242 • Number of events 30 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Psychiatric disorders Insomnia	3.8% 9/239 • Number of events 16 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	5.0% 12/242 • Number of events 20 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Psychiatric disorders Libido decreased	1.3% 3/239 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Psychiatric disorders Orgasm abnormal	20.9% 50/239 • Number of events 124 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	16.1% 39/242 • Number of events 95 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Psychiatric disorders Psychosis	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Reproductive system and breast disorders Breast pain	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Reproductive system and breast disorders Ejaculation disorder	1.3% 3/239 • Number of events 8 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Reproductive system and breast disorders Erectile dysfunction	27.2% 65/239 • Number of events 177 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	26.4% 64/242 • Number of events 152 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Reproductive system and breast disorders Gynecomastia	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Reproductive system and breast disorders Irregular menstruation	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Reproductive system and breast disorders Pelvic pain	1.7% 4/239 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.2% 3/242 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Reproductive system and breast disorders Penile pain	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Reproductive system and breast disorders Perineal pain	2.1% 5/239 • Number of events 11 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	4.5% 11/242 • Number of events 26 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Reproductive system and breast disorders Reproductive tract disorder	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Reproductive system and breast disorders Vaginal atresia	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Reproductive system and breast disorders Vaginal discharge	0.84% 2/239 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Reproductive system and breast disorders Vaginal dryness	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.2% 3/242 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Reproductive system and breast disorders Vaginal hemorrhage	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Reproductive system and breast disorders Vaginal inflammation	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Reproductive system and breast disorders Vaginal pain	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Reproductive system and breast disorders Vaginal stricture	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.2% 3/242 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Aspiration	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.42% 1/239 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Chylothorax	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Cough	2.5% 6/239 • Number of events 12 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.1% 5/242 • Number of events 5 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.8% 9/239 • Number of events 13 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	4.5% 11/242 • Number of events 14 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Hemorrhage nasal	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Hiccough	0.84% 2/239 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.1% 5/239 • Number of events 5 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.2% 3/242 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Laryngeal edema	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Mediastinal hemorrhage	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.84% 2/239 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	2.9% 7/239 • Number of events 7 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.1% 5/242 • Number of events 5 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Respiratory, thoracic and mediastinal disorders Voice alteration	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.5% 6/242 • Number of events 7 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.5% 6/242 • Number of events 10 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Skin and subcutaneous tissue disorders Dry skin	1.3% 3/239 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.7% 4/242 • Number of events 5 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Skin and subcutaneous tissue disorders Erythema multiforme	0.42% 1/239 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Skin and subcutaneous tissue disorders Hand-and-foot syndrome	1.3% 3/239 • Number of events 5 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.2% 3/242 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Skin and subcutaneous tissue disorders Pain of skin	0.84% 2/239 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Skin and subcutaneous tissue disorders Petechiae	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Skin and subcutaneous tissue disorders Pruritus	3.3% 8/239 • Number of events 11 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.5% 6/242 • Number of events 6 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Skin and subcutaneous tissue disorders Rash acneiform	0.84% 2/239 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Skin and subcutaneous tissue disorders Rash desquamating	4.6% 11/239 • Number of events 15 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.1% 5/242 • Number of events 7 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Skin and subcutaneous tissue disorders Skin disorder	5.0% 12/239 • Number of events 18 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	7.9% 19/242 • Number of events 29 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Skin and subcutaneous tissue disorders Skin induration	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.00% 0/242 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Skin and subcutaneous tissue disorders Skin ulceration	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.7% 4/242 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Skin and subcutaneous tissue disorders Sweating	0.84% 2/239 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	1.7% 4/242 • Number of events 4 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Vascular disorders Hematoma	2.5% 6/239 • Number of events 7 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.1% 5/242 • Number of events 5 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Vascular disorders Hemorrhage	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Vascular disorders Hot flashes	1.3% 3/239 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.83% 2/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Vascular disorders Hypertension	1.3% 3/239 • Number of events 3 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	2.9% 7/242 • Number of events 9 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Vascular disorders Hypotension	5.0% 12/239 • Number of events 13 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	3.3% 8/242 • Number of events 9 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Vascular disorders Lymph leakage	0.00% 0/239 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Vascular disorders Thrombosis	4.2% 10/239 • Number of events 14 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	3.7% 9/242 • Number of events 10 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
Vascular disorders Vascular disorder	0.42% 1/239 • Number of events 1 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.	0.41% 1/242 • Number of events 2 • Adverse Events were collected after surgery and were collected up to 30 days after surgery. All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.

Additional Information

Tonia M. Young-Fadok, M.D.

Mayo Clinic

Email: youngfadok.tonia@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place