Trial Outcomes & Findings for Efficacy of Delayed Coloanal Anastomosis for Medium and Lower Rectum Cancer Treatment. Phase 2 Clinical Trial (CASCADOR) (NCT NCT01876901)

Last Updated: 2025-09-04

Results Overview

Efficacy of the intervention was defined as the absence at day 30 of a symptomatic AL (either with entero-cutaneous fistula or perianastomotic abscess with infectious conditions and/or transit impairment) requiring diverting stoma (curatively for 2-stage CA or prophylactic-based for CA). AL was defined as fecal matter in the drainage system when a drainage system was present. Clinical signs included fever and subocclusion requiring a pelvic scan and collection of liquid and gas in the peri-anastomotic region. Non-symptomatic ALs which did not require any investigation nor treatment, in particular no diverting stoma, were not considered failures. Assuming an efficacy rates of 85% (null hypothesis) and 95% (alternative hypothesis), and relied on a superiority test at the 5% significance level (one-sided) with 80% power, 53 eligible and assessable patients were required. Efficacy of the intervention was concluded if at least 49 patients had no symptomatic AL at day 30.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

124 participants

Primary outcome timeframe

Delayed coloanal anastomosis effectiveness was evaluated in terms of symptomatic anastomotic fistula occurring during the 30 days post anastomosis and requiring stoma derivation.

Results posted on

2025-09-04

Participant Flow

Participant milestones

Participant milestones
Measure	2-stage Pull-through Colo-anal Anastomosis Without Prophylactic Derivation (2SCA) Patients treated with 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention. 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA): 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy. After surgical resection, the colon is exteriorized through the anus and attached to the buttock. By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation	Colo-anal Anastomosis (CAA) Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention. Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often. In the absence of fistula, the patient will reoperation for stoma closure of its branch
Overall Study STARTED	65	59
Overall Study COMPLETED	48	52
Overall Study NOT COMPLETED	17	7

Reasons for withdrawal

Reasons for withdrawal
Measure	2-stage Pull-through Colo-anal Anastomosis Without Prophylactic Derivation (2SCA) Patients treated with 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention. 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA): 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy. After surgical resection, the colon is exteriorized through the anus and attached to the buttock. By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation	Colo-anal Anastomosis (CAA) Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention. Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often. In the absence of fistula, the patient will reoperation for stoma closure of its branch
Overall Study Protocol Violation	10	2
Overall Study No or other surgical intervention	7	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	2-stage Pull-through Colo-anal Anastomosis Without Prophylactic Derivation (2SCA) n=48 Participants Patients treated with 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention. 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA): 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy. After surgical resection, the colon is exteriorized through the anus and attached to the buttock. By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation	Colo-anal Anastomosis (CAA) n=52 Participants Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention. Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often. In the absence of fistula, the patient will reoperation for stoma closure of its branch	Total n=100 Participants Total of all reporting groups
Age, Continuous	61 years n=48 Participants	63 years n=52 Participants	62 years n=100 Participants
Sex: Female, Male Female	19 Participants n=48 Participants	24 Participants n=52 Participants	43 Participants n=100 Participants
Sex: Female, Male Male	29 Participants n=48 Participants	28 Participants n=52 Participants	57 Participants n=100 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	48 participants n=48 Participants	52 participants n=52 Participants	100 participants n=100 Participants

PRIMARY outcome

Timeframe: Delayed coloanal anastomosis effectiveness was evaluated in terms of symptomatic anastomotic fistula occurring during the 30 days post anastomosis and requiring stoma derivation.

Population: Eligible patient (without major protocol deviation) which was operated with complete 2SCA procedure.

Outcome measures

Outcome measures
Measure	2-stage Pull-through Colo-anal Anastomosis Without Prophylactic Derivation (2SCA) n=48 Participants Patients treated with 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention. 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA): 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy. After surgical resection, the colon is exteriorized through the anus and attached to the buttock. By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation	Colo-anal Anastomosis (CAA) Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention. Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often. In the absence of fistula, the patient will reoperation for stoma closure of its branch
Absence at Day 30 of a Symptomatic Anastomotic Leakage (AL) Among 2SCA	1 Participants	—

SECONDARY outcome

Timeframe: Presence of stomata bypass was evaluated at 30 days, 1 year and 2 years after surgery (2SCA or CAA)

Population: Eligible patient (without major protocol deviation) which was operated with complete 2SCA procedure and CAA for 2SCA group and CAA group respectively.

Number of patients with stomata bypass (preventive or therapeutic) at each time of follow-up after surgery (2SCA or CAA). A stomata bypass is the result of a surgical operation in which a damaged part is removed from the ileum (ileostomy) or colon (colostomy) and the cut end diverted to an artificial opening in the abdominal wall.

Outcome measures

Outcome measures
Measure	2-stage Pull-through Colo-anal Anastomosis Without Prophylactic Derivation (2SCA) n=48 Participants Patients treated with 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention. 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA): 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy. After surgical resection, the colon is exteriorized through the anus and attached to the buttock. By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation	Colo-anal Anastomosis (CAA) n=52 Participants Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention. Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often. In the absence of fistula, the patient will reoperation for stoma closure of its branch
Stomata Bypass (Preventive or Therapeutic) 30 days	2 Participants	49 Participants
Stomata Bypass (Preventive or Therapeutic) 1 year	3 Participants	3 Participants
Stomata Bypass (Preventive or Therapeutic) 2 years	6 Participants	8 Participants

SECONDARY outcome

Timeframe: During the 30 first days after surgery (2SCA or CAA)

Population: Eligible patient (without major protocol deviation) which was operated with complete 2SCA procedure and CAA for 2SCA group and CAA group respectively.

Post-operative morbidity was assessed in terms number of patients with at least one surgical complications related to treatment and related to a serious adverse event.

Outcome measures

Outcome measures
Measure	2-stage Pull-through Colo-anal Anastomosis Without Prophylactic Derivation (2SCA) n=48 Participants Patients treated with 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention. 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA): 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy. After surgical resection, the colon is exteriorized through the anus and attached to the buttock. By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation	Colo-anal Anastomosis (CAA) n=52 Participants Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention. Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often. In the absence of fistula, the patient will reoperation for stoma closure of its branch
Post-operative Morbidity	13 Participants	10 Participants

SECONDARY outcome

Timeframe: From the date of surgery to 30 days after surgery (2SCA or CAA)

Population: Eligible patient (without major protocol deviation) which was operated with complete 2SCA procedure and CAA for 2SCA group and CAA group respectively.

Postoperative mortality was defined by the number of patients who deceased (all cause mortality) during the first 30 days after surgery (2SCA or CAA).

Outcome measures

Outcome measures
Measure	2-stage Pull-through Colo-anal Anastomosis Without Prophylactic Derivation (2SCA) n=48 Participants Patients treated with 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention. 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA): 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy. After surgical resection, the colon is exteriorized through the anus and attached to the buttock. By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation	Colo-anal Anastomosis (CAA) n=52 Participants Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention. Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often. In the absence of fistula, the patient will reoperation for stoma closure of its branch
Postoperative Mortality	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 and 2 years after surgery (2SCA or CAA)

Population: Eligible patient (without major protocol deviation) which was operated with complete 2SCA procedure and CAA for 2SCA group and CAA group respectively.

Progression-free survival (PFS) was defined as the time from the date of surgery and the date of the earliest of the following events: * The patient's death, whatever the cause, * Local progression or remotely. Progression was defined as clinical or radioglogical progression. Radiological progression was defined Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions" 1-year and 2-year progression-free rates were estimated.

Outcome measures

Outcome measures
Measure	2-stage Pull-through Colo-anal Anastomosis Without Prophylactic Derivation (2SCA) n=48 Participants Patients treated with 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention. 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA): 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy. After surgical resection, the colon is exteriorized through the anus and attached to the buttock. By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation	Colo-anal Anastomosis (CAA) n=52 Participants Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention. Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often. In the absence of fistula, the patient will reoperation for stoma closure of its branch
Progression-free Survival 1-year PFS	76.5 percentage or paticipants Interval 61.5 to 86.2	92.2 percentage or paticipants Interval 80.6 to 97.0
Progression-free Survival 2-years PFS	63.3 percentage or paticipants Interval 47.7 to 75.4	81.3 percentage or paticipants Interval 66.9 to 89.9

SECONDARY outcome

Timeframe: At 6 months after surgery (2SCA or CAA)

Population: Eligible patient (without major protocol deviation) which was operated with complete 2SCA procedure and CAA for 2SCA group and CAA group respectively and who responded to the questionnaire.

The digestive functions, especially anal incontinence was evaluated according to the scale of 5 items Jorge and Wexner (score from 0 to 20). The rate of patients with anal incontinence (score \>=5) at 6 months was reported.

Outcome measures

Outcome measures
Measure	2-stage Pull-through Colo-anal Anastomosis Without Prophylactic Derivation (2SCA) n=25 Participants Patients treated with 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention. 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA): 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy. After surgical resection, the colon is exteriorized through the anus and attached to the buttock. By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation	Colo-anal Anastomosis (CAA) n=39 Participants Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention. Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often. In the absence of fistula, the patient will reoperation for stoma closure of its branch
Number of Participants With Anal Incontinence at 6 Months	25 Participants	32 Participants

SECONDARY outcome

Timeframe: At 12 months after surgery (2SCA or CAA)

Outcome measures

Outcome measures
Measure	2-stage Pull-through Colo-anal Anastomosis Without Prophylactic Derivation (2SCA) n=16 Participants Patients treated with 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention. 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA): 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy. After surgical resection, the colon is exteriorized through the anus and attached to the buttock. By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation	Colo-anal Anastomosis (CAA) n=40 Participants Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention. Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often. In the absence of fistula, the patient will reoperation for stoma closure of its branch
Number of Participants With Anal Incontinence at 12 Months	15 Participants	36 Participants

SECONDARY outcome

Timeframe: At 24 months after surgery (2SCA or CAA)

Outcome measures

Outcome measures
Measure	2-stage Pull-through Colo-anal Anastomosis Without Prophylactic Derivation (2SCA) n=12 Participants Patients treated with 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention. 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA): 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy. After surgical resection, the colon is exteriorized through the anus and attached to the buttock. By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation	Colo-anal Anastomosis (CAA) n=33 Participants Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention. Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often. In the absence of fistula, the patient will reoperation for stoma closure of its branch
Number of Participants With Anal Incontinence at 24 Months	11 Participants	29 Participants

SECONDARY outcome

Timeframe: Colo-anal anastomosis effectiveness will be evaluated in terms of symptomatic anastomotic fistula occurring during the 30 days post anastomosis and requiring stoma derivation.

Population: Eligible patient (without major protocol deviation) which was operated with complete CAA procedure.

Efficacy of the intervention was defined as the absence at day 30 of a symptomatic AL (either with entero-cutaneous fistula or perianastomotic abscess with infectious conditions and/or transit impairment) requiring diverting stoma. AL was defined as fecal matter in the drainage system when a drainage system was present. Clinical signs included fever and subocclusion requiring a pelvic scan and collection of liquid and gas in the peri-anastomotic region. Non-symptomatic ALs which did not require any investigation nor treatment, in particular no diverting stoma, were not considered failures. The effectiveness of the CAA surgery will be evaluated in terms of absence of fistula requiring stoma diversion. Similarly to 2SCA group, 53 CAA eligible and evaluable patients will be required. If 49 or more patients (out of 53) have no fistula requiring stoma diversion, then we conclude that the CAA is effective. To anticipate any non evaluable patients, we plan to recruit 58 patients CAA.

Outcome measures

Outcome measures
Measure	2-stage Pull-through Colo-anal Anastomosis Without Prophylactic Derivation (2SCA) n=52 Participants Patients treated with 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention. 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA): 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy. After surgical resection, the colon is exteriorized through the anus and attached to the buttock. By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation	Colo-anal Anastomosis (CAA) Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention. Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often. In the absence of fistula, the patient will reoperation for stoma closure of its branch
Absence at Day 30 of a Symptomatic Anastomotic Leakage (AL) Among CAA	5 Participants	—

Adverse Events

2-stage Pull-through Colo-anal Anastomosis Without Prophylactic Derivation (2SCA)

Serious events: 30 serious events

Other events: 0 other events

Deaths: 4 deaths

Colo-anal Anastomosis (CAA)

Serious events: 24 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Pr Simone Mathoulin-Pelissier

Institut Bergonié

Phone: 0556333333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	2-stage Pull-through Colo-anal Anastomosis Without Prophylactic Derivation (2SCA) n=48 participants at risk Patients treated with 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention. 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA): 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy. After surgical resection, the colon is exteriorized through the anus and attached to the buttock. By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation	Colo-anal Anastomosis (CAA) n=52 participants at risk Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention. Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often. In the absence of fistula, the patient will reoperation for stoma closure of its branch
Cardiac disorders Cardiac ischemia/infarction	2.1% 1/48 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/52 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
General disorders ALTERED GENERAL CONDITION	4.2% 2/48 • Number of events 2 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	1.9% 1/52 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Surgical and medical procedures ABDOMINO PERINEAL AMPUTATION FOR RECURRENCE OF RECTAL ADENOCARCINOMA	2.1% 1/48 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/52 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Surgical and medical procedures MANAGEMENT OF HEPATIC METASTASES OF THE ANTERIOR BORDER OF SEGMENT VII	2.1% 1/48 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/52 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Surgical and medical procedures LEFT COLON LUMPECTOMY	2.1% 1/48 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/52 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic metastasis	2.1% 1/48 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/52 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
General disorders DISEASE PROGRESSION	0.00% 0/48 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/52 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METACHRONOUS LIVER METASTASES OF RECTAL ADENOCARCINOMA	0.00% 0/48 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	1.9% 1/52 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic recurrence	0.00% 0/48 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	1.9% 1/52 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ANASTOMOTIC RECURRENCE	0.00% 0/48 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	1.9% 1/52 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LOCAL AND METASTATIC RECURRENCE (LUNGS)	0.00% 0/48 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	1.9% 1/52 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HEPATIC EVOLUTIONARY RECOVERY	0.00% 0/48 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	1.9% 1/52 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PELVIC TUMOR RECURRENCE	0.00% 0/48 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	1.9% 1/52 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Skin and subcutaneous tissue disorders PERISTOMAL DERMATITIS ASSOCIATED WITH SKIN ULCERATION	2.1% 1/48 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/52 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Gastrointestinal disorders Ascites (non-malignant)	0.00% 0/48 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	1.9% 1/52 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Gastrointestinal disorders Constipation	2.1% 1/48 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/52 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Gastrointestinal disorders Diarrhea	2.1% 1/48 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/52 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Gastrointestinal disorders Fistula, GI	4.2% 2/48 • Number of events 2 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	7.7% 4/52 • Number of events 5 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Gastrointestinal disorders Anitis	2.1% 1/48 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/52 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Gastrointestinal disorders RECTAL RESECTION SYNDROME	0.00% 0/48 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	1.9% 1/52 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Gastrointestinal disorders Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)	0.00% 0/48 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	3.8% 2/52 • Number of events 2 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Gastrointestinal disorders Incontinence, anal	0.00% 0/48 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	5.8% 3/52 • Number of events 3 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Gastrointestinal disorders Necrosis, GI	4.2% 2/48 • Number of events 2 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/52 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Gastrointestinal disorders Obstruction, GI	12.5% 6/48 • Number of events 6 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	5.8% 3/52 • Number of events 3 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Gastrointestinal disorders Stricture/stenosis (including anastomotic), GI	8.3% 4/48 • Number of events 4 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	5.8% 3/52 • Number of events 4 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Vascular disorders Hematoma	4.2% 2/48 • Number of events 3 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	1.9% 1/52 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Injury, poisoning and procedural complications Hemorrhage/bleeding associated with surgery, intra-operative or postoperative	2.1% 1/48 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/52 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Infections and infestations Infection with unknown ANC	27.1% 13/48 • Number of events 20 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	23.1% 12/52 • Number of events 18 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Nervous system disorders CNS cerebrovascular ischemia	2.1% 1/48 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/52 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Psychiatric disorders Cognitive disturbance	0.00% 0/48 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	1.9% 1/52 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Psychiatric disorders Psychosis (hallucinations/delusions)	2.1% 1/48 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/52 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
General disorders Pain	2.1% 1/48 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/52 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	2.1% 1/48 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/52 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	0.00% 0/48 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	3.8% 2/52 • Number of events 2 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Renal and urinary disorders Stricture/stenosis (including anastomotic), GU	2.1% 1/48 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/52 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Renal and urinary disorders Urinary retention (including neurogenic bladder)	4.2% 2/48 • Number of events 2 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	3.8% 2/52 • Number of events 2 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Reproductive system and breast disorders Erectile dysfunction	2.1% 1/48 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	3.8% 2/52 • Number of events 2 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Injury, poisoning and procedural complications EVENTRATION	6.2% 3/48 • Number of events 3 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	7.7% 4/52 • Number of events 4 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Injury, poisoning and procedural complications BILATERAL INGUINAL HERNIA	0.00% 0/48 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	1.9% 1/52 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Injury, poisoning and procedural complications STOMAL PROLAPSE	2.1% 1/48 • Number of events 1 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/52 • From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months. Only Serious Adverse events were collected following NCI-CTCAE (3.0). Other \[Not Including Serious\] Adverse Events were not monitored/assessed.