Trial Outcomes & Findings for SILS™ Port Laparoscopic Cholecystectomy Post Market Study (NCT NCT00832767)

Results Overview

Feasibility and safety as determined by intraoperative and postoperative adverse events.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

202 participants

Primary outcome timeframe

One year

Results posted on

2017-12-18

Participant Flow

Participant milestones

Participant milestones
Measure	SILS Port SILS™ Port Laparoscopic Cholecystectomy SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure.	Four Port Four Port Laparoscopic Cholecystectomy Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.
Overall Study STARTED	121	81
Overall Study COMPLETED	99	63
Overall Study NOT COMPLETED	22	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SILS™ Port Laparoscopic Cholecystectomy Post Market Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SILS Port n=119 Participants SILS™ Port Laparoscopic Cholecystectomy SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure.	Four Port n=81 Participants Four Port Laparoscopic Cholecystectomy Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.	Total n=200 Participants Total of all reporting groups
Age, Customized	45.8 years n=5 Participants	44.0 years n=7 Participants	44.9 years n=5 Participants
Sex: Female, Male Female	91 Participants n=5 Participants	57 Participants n=7 Participants	148 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	24 Participants n=7 Participants	52 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants	7 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) White	85 Participants n=5 Participants	61 Participants n=7 Participants	146 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: One year

Feasibility and safety as determined by intraoperative and postoperative adverse events.

Outcome measures

Outcome measures
Measure	SILS Port n=119 Participants SILS™ Port Laparoscopic Cholecystectomy SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure.	Four Port n=81 Participants Four Port Laparoscopic Cholecystectomy Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.
Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC At least one AE	53 Participants	29 Participants
Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC At least one SAE	14 Participants	5 Participants
Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC At least one Device-Related AE or SAE	6 Participants	1 Participants
Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC At least one procedure-related AE or SAE	45 Participants	23 Participants

PRIMARY outcome

Timeframe: Day 0

Population: One site did not collect the operative time for a patient in the SILS group

Duration of surgical procedure in minutes.

Outcome measures

Outcome measures
Measure	SILS Port n=118 Participants SILS™ Port Laparoscopic Cholecystectomy SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure.	Four Port n=81 Participants Four Port Laparoscopic Cholecystectomy Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.
Operative Time	56.8 minutes Standard Deviation 23.2	45.3 minutes Standard Deviation 17.1

PRIMARY outcome

Timeframe: Day 0

Blood loss from surgical procedure in cc.

Outcome measures

Outcome measures
Measure	SILS Port n=119 Participants SILS™ Port Laparoscopic Cholecystectomy SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure.	Four Port n=81 Participants Four Port Laparoscopic Cholecystectomy Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.
Estimated Blood Loss	14.9 cc Standard Deviation 35.5	14.1 cc Standard Deviation 35.4

SECONDARY outcome

Timeframe: Various (Pre-operative, Day 0, 1,3, 5, 1 Week, 2 Week and 1 Month)

Population: Number includes patients who completed pain evaluation questionnaire.

Pain evaluation as determined by a 10-point pain intensity numerical rating scale (PI-NRS) ranging from 0 (no pain) to 10 (worst possible pain).

Outcome measures

Outcome measures
Measure	SILS Port n=119 Participants SILS™ Port Laparoscopic Cholecystectomy SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure.	Four Port n=81 Participants Four Port Laparoscopic Cholecystectomy Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.
Average Pain Experienced in the Last 24 Hours at Various Time Frames Pre-operative	3.1 units on a scale Standard Deviation 2.7	3.3 units on a scale Standard Deviation 2.8
Average Pain Experienced in the Last 24 Hours at Various Time Frames Day 0 (Post-operative)	6.3 units on a scale Standard Deviation 2.8	6.4 units on a scale Standard Deviation 2.3
Average Pain Experienced in the Last 24 Hours at Various Time Frames Day 1	6.7 units on a scale Standard Deviation 2.5	6.1 units on a scale Standard Deviation 2.0
Average Pain Experienced in the Last 24 Hours at Various Time Frames Day 3	5.4 units on a scale Standard Deviation 2.3	4.6 units on a scale Standard Deviation 2.1
Average Pain Experienced in the Last 24 Hours at Various Time Frames Day 5	4.2 units on a scale Standard Deviation 2.2	3.5 units on a scale Standard Deviation 2.1
Average Pain Experienced in the Last 24 Hours at Various Time Frames 1 Week	3.5 units on a scale Standard Deviation 2.3	2.9 units on a scale Standard Deviation 2.0
Average Pain Experienced in the Last 24 Hours at Various Time Frames 2 Weeks	2.0 units on a scale Standard Deviation 1.5	1.9 units on a scale Standard Deviation 1.5
Average Pain Experienced in the Last 24 Hours at Various Time Frames 1 Month	1.8 units on a scale Standard Deviation 1.9	1.5 units on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)

Population: The number includes participants who completed the Body Image Questionnaire.

The Body Image Scale consists of Questions 1-5 on the Body Image Questionnaire. Here, subjects were asked to answer each question on a scale from 1 to 4 with 1 being the best. Therefore, a total score of 5-20 was calculated for each patient with 5 being the best.

Outcome measures

Outcome measures
Measure	SILS Port n=116 Participants SILS™ Port Laparoscopic Cholecystectomy SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure.	Four Port n=80 Participants Four Port Laparoscopic Cholecystectomy Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.
Body Image Scale 1 Week	5.6 units on a scale Standard Deviation 1.4	5.8 units on a scale Standard Deviation 1.4
Body Image Scale 2 Weeks	5.6 units on a scale Standard Deviation 1.4	5.8 units on a scale Standard Deviation 1.4
Body Image Scale 1 Month	5.5 units on a scale Standard Deviation 1.5	5.8 units on a scale Standard Deviation 1.7
Body Image Scale 3 Month	5.3 units on a scale Standard Deviation 1.0	5.5 units on a scale Standard Deviation 1.2
Body Image Scale 1 Year	5.5 units on a scale Standard Deviation 1.6	5.8 units on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)

Population: The number includes participants who completed the Cosmetic Scale

The Cosmetic Scale consists of Questions 6-8 on the Body Image Questionnaire. Here, patients were asked to answer questions regarding the cosmesis of their own scar (SILS™) or scars (4PLC). The first 2 questions were answered on a scale from 1 to 7 and Question 8 from 1 to 10, both with 1 being the worst. Therefore, a total score of 3-24 was calculated for each patient with 3 being the worst.

Outcome measures

Outcome measures
Measure	SILS Port n=116 Participants SILS™ Port Laparoscopic Cholecystectomy SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure.	Four Port n=80 Participants Four Port Laparoscopic Cholecystectomy Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.
Cosmetic Scale 1 Week	20.5 units on a scale Standard Deviation 3.6	18.6 units on a scale Standard Deviation 3.9
Cosmetic Scale 2 Weeks	21.5 units on a scale Standard Deviation 3.1	18.5 units on a scale Standard Deviation 3.9
Cosmetic Scale 1 Month	22.1 units on a scale Standard Deviation 2.7	19.2 units on a scale Standard Deviation 3.8
Cosmetic Scale 3 Month	22.5 units on a scale Standard Deviation 2.6	20.0 units on a scale Standard Deviation 3.3
Cosmetic Scale 1 Year	22.6 units on a scale Standard Deviation 2.4	20.2 units on a scale Standard Deviation 3.7

SECONDARY outcome

Timeframe: Change from Baseline (Pre-Op) at 1 Week, 2 Week, 1 Month, 3 Month and 1 Year

Population: The number analyzed includes participants who completed questions 9 \& 10 on the Body Image Questionnaire. Mean Change from Baseline (Pre-Op).

The Confidence Scale consists of Questions 9 and 10 on the Body Image Questionnaire. One question is before procedure and another is after procedure. The Patients were asked to rate their overall confidence before (baseline) and after the procedure. The scores for before/after procedure range from 1 to 10 with 1 being "not very confident" and 10 being "very confident". The score difference from the before/after treatment is compared between the two procedures (4PLC and SILS™) Here, a positive score indicates that patient confidence has increased.

Outcome measures

Outcome measures
Measure	SILS Port n=116 Participants SILS™ Port Laparoscopic Cholecystectomy SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure.	Four Port n=80 Participants Four Port Laparoscopic Cholecystectomy Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.
Confidence Scale Change From Baseline 1 Week	0.5 units on a scale Standard Deviation 2.2	0.5 units on a scale Standard Deviation 2.4
Confidence Scale Change From Baseline 2 Weeks	0.7 units on a scale Standard Deviation 2.3	0.6 units on a scale Standard Deviation 2.2
Confidence Scale Change From Baseline 1 Month	0.5 units on a scale Standard Deviation 2.0	0.6 units on a scale Standard Deviation 1.8
Confidence Scale Change From Baseline 3 Month	1.0 units on a scale Standard Deviation 2.3	0.6 units on a scale Standard Deviation 1.8
Confidence Scale Change From Baseline 1 Year	1.1 units on a scale Standard Deviation 2.3	0.9 units on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)

Population: The number includes all participants who completed the Photo Series Questionnaire.

Photo Series Questionnaire (PSQ). All subjects were asked to score their own scar (Question 1), then rate 2 standardized photos (one of 4PLC scars and one of a SILS™ scar) (Questions 2 and 3, respectively) and finally rate their own scar again after viewing the photos (Question 4). All scars were rated on a scale from 1 to 10 with 10 being the best. Normalized scores were analyzed for the photo questionnaire. In order to calculate the normalized score, each patient's score of the 4PLC photo was subtracted from their score of their own scar before viewing the photos. the median values were then used to calculate statistical significance. Normalized Scores of Own Scar are reported below: Question 1 - Question 2 (Q1 - Q2) Question 4 - Question 2 (Q4 - Q2) In order to calculate the normalized score for the subject's own scar, Q2 was used as baseline score since Q2 was the score for the conventional procedure 4PLC.

Outcome measures

Outcome measures
Measure	SILS Port n=119 Participants SILS™ Port Laparoscopic Cholecystectomy SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure.	Four Port n=81 Participants Four Port Laparoscopic Cholecystectomy Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.
Normalized Scar Scores Week 1 Q1 - Q2	2.8 units on a scale Standard Deviation 2.9	0.9 units on a scale Standard Deviation 1.9
Normalized Scar Scores Week 1 Q4 - Q2	3.1 units on a scale Standard Deviation 2.9	0.6 units on a scale Standard Deviation 2.0
Normalized Scar Scores Week 2 Q1 - Q2	2.5 units on a scale Standard Deviation 2.5	0.4 units on a scale Standard Deviation 1.4
Normalized Scar Scores Week 2 Q4 - Q2	2.7 units on a scale Standard Deviation 2.6	0.3 units on a scale Standard Deviation 1.8
Normalized Scar Scores Month 1 Q1 - Q2	2.8 units on a scale Standard Deviation 2.3	0.7 units on a scale Standard Deviation 1.5
Normalized Scar Scores Month 1 Q4 - Q2	2.9 units on a scale Standard Deviation 2.3	0.2 units on a scale Standard Deviation 1.9
Normalized Scar Scores Month 3 Q1 - Q2	3.0 units on a scale Standard Deviation 2.4	0.4 units on a scale Standard Deviation 1.3
Normalized Scar Scores Month 3 Q4 - Q2	3.0 units on a scale Standard Deviation 2.4	0.1 units on a scale Standard Deviation 1.3
Normalized Scar Scores Year 1 Q1 - Q2	1.9 units on a scale Standard Deviation 2.0	-0.0 units on a scale Standard Deviation 1.3
Normalized Scar Scores Year 1 Q4 - Q2	2.0 units on a scale Standard Deviation 1.9	-0.2 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)

Population: The number includes all participants where Modified Hollander Score was completed.

Surgeons were asked to answer 6 questions regarding the appearance of their subjects' scars. Each patient's score was summed for a total score 0 to 6 with 0 being the best.

Outcome measures

Outcome measures
Measure	SILS Port n=115 Participants SILS™ Port Laparoscopic Cholecystectomy SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure.	Four Port n=80 Participants Four Port Laparoscopic Cholecystectomy Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.
Modified Hollander 1 Week	0.37 units on a scale Standard Deviation 0.93	0.21 units on a scale Standard Deviation 0.67
Modified Hollander 2 Weeks	0.15 units on a scale Standard Deviation 0.48	0.06 units on a scale Standard Deviation 0.29
Modified Hollander 3 Month	0.05 units on a scale Standard Deviation 0.27	0.01 units on a scale Standard Deviation 0.12
Modified Hollander 1 Year	0.12 units on a scale Standard Deviation 0.46	0.03 units on a scale Standard Deviation 0.18
Modified Hollander 1 Month	0.10 units on a scale Standard Deviation 0.35	0.14 units on a scale Standard Deviation 0.51

SECONDARY outcome

Timeframe: Various (Baseline (Pre-Op), Day 1, 3, 5 and 1 Week)

Population: Number includes all participants who completed SF8 Quality of Life Questionnaire.

SF8 questionnaire was used. This scale measures health and well-being and asks patients to rank their quality of life on a scale of 1 to 5 or a scale of 1 to 6 with 1 being the best and 5 or 6 being the worst. The quality of life questionnaire contains both physical and mental components. The raw scores are translated into one from 0 to 100, with 0 representing a very low level of QoL and 100 representing a higher QoL.

Outcome measures

Outcome measures
Measure	SILS Port n=119 Participants SILS™ Port Laparoscopic Cholecystectomy SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure.	Four Port n=80 Participants Four Port Laparoscopic Cholecystectomy Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.
Physical Quality of Life Baseline (Pre-Op)	49.1 units on a scale Standard Deviation 10.3	50.1 units on a scale Standard Deviation 9.2
Physical Quality of Life Day 1	31.0 units on a scale Standard Deviation 9.9	31.8 units on a scale Standard Deviation 8.3
Physical Quality of Life Day 3	36.8 units on a scale Standard Deviation 9.3	40.1 units on a scale Standard Deviation 8.8
Physical Quality of Life Day 5	42.0 units on a scale Standard Deviation 8.6	44.1 units on a scale Standard Deviation 10.6
Physical Quality of Life 1 Week	44.4 units on a scale Standard Deviation 9.3	47.5 units on a scale Standard Deviation 6.5

SECONDARY outcome

Timeframe: Various (Baseline (Pre-Op), Day 1, 3, 5 and 1 Week)

Population: The number includes participants who completed the SF8 questionnaire.

SF8 scale was used. This scale measures health and well-being and asks patients to rank their quality of life on a scale of 1 to 5 or a scale of 1 to 6 with 1 being the best and 5 or 6 being the worst. The quality of life questionnaire contains both physical and mental components. The raw scores are translated into one from 0 to 100, with 0 representing a very low level of QoL and 100 representing a higher QoL.

Outcome measures

Outcome measures
Measure	SILS Port n=119 Participants SILS™ Port Laparoscopic Cholecystectomy SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure.	Four Port n=80 Participants Four Port Laparoscopic Cholecystectomy Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.
Mental Quality of Life Day 1	49.0 units on a scale Standard Deviation 11.2	50.6 units on a scale Standard Deviation 9.4
Mental Quality of Life Day 3	51.4 units on a scale Standard Deviation 8.6	51.3 units on a scale Standard Deviation 8.6
Mental Quality of Life Day 5	52.4 units on a scale Standard Deviation 7.8	53.3 units on a scale Standard Deviation 7.4
Mental Quality of Life 1 Week	52.0 units on a scale Standard Deviation 8.3	53.4 units on a scale Standard Deviation 7.2
Mental Quality of Life Baseline (Pre-Op)	47.2 units on a scale Standard Deviation 10.9	49.1 units on a scale Standard Deviation 9.4

SECONDARY outcome

Timeframe: Day 0

Time required to insert SILS port system or 4 individual ports was captured for each procedure in minutes.

Outcome measures

Outcome measures
Measure	SILS Port n=119 Participants SILS™ Port Laparoscopic Cholecystectomy SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure.	Four Port n=81 Participants Four Port Laparoscopic Cholecystectomy Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.
Time to Cannulization	6.3 minutes Standard Deviation 4.4	6.9 minutes Standard Deviation 3.9

Adverse Events

SILS Port

Serious events: 15 serious events

Other events: 44 other events

Deaths: 0 deaths

Four Port

Serious events: 5 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	SILS Port n=119 participants at risk SILS™ Port Laparoscopic Cholecystectomy SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure.	Four Port n=81 participants at risk Four Port Laparoscopic Cholecystectomy Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.
Gastrointestinal disorders Diarrhoea	7.6% 9/119 • Number of events 10 • AEs collected from enrollment through end of study which was a period of 1 year.	7.4% 6/81 • Number of events 6 • AEs collected from enrollment through end of study which was a period of 1 year.
Gastrointestinal disorders Nausea	9.2% 11/119 • Number of events 12 • AEs collected from enrollment through end of study which was a period of 1 year.	7.4% 6/81 • Number of events 7 • AEs collected from enrollment through end of study which was a period of 1 year.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	8.4% 10/119 • Number of events 10 • AEs collected from enrollment through end of study which was a period of 1 year.	8.6% 7/81 • Number of events 7 • AEs collected from enrollment through end of study which was a period of 1 year.
Gastrointestinal disorders Abdominal Pain	11.8% 14/119 • Number of events 15 • AEs collected from enrollment through end of study which was a period of 1 year.	9.9% 8/81 • Number of events 8 • AEs collected from enrollment through end of study which was a period of 1 year.

Additional Information

Jessica Carlson

Covidien

Phone: 203-821-4734

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	SILS Port n=119 participants at risk SILS™ Port Laparoscopic Cholecystectomy SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure.	Four Port n=81 participants at risk Four Port Laparoscopic Cholecystectomy Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.
Gastrointestinal disorders Abdominal hernia	1.7% 2/119 • Number of events 2 • AEs collected from enrollment through end of study which was a period of 1 year.	0.00% 0/81 • AEs collected from enrollment through end of study which was a period of 1 year.
Gastrointestinal disorders Abdominal pain	1.7% 2/119 • Number of events 2 • AEs collected from enrollment through end of study which was a period of 1 year.	0.00% 0/81 • AEs collected from enrollment through end of study which was a period of 1 year.
Cardiac disorders Angina Pectoris	0.84% 1/119 • Number of events 1 • AEs collected from enrollment through end of study which was a period of 1 year.	0.00% 0/81 • AEs collected from enrollment through end of study which was a period of 1 year.
Hepatobiliary disorders Bile Duct Stone	0.84% 1/119 • Number of events 1 • AEs collected from enrollment through end of study which was a period of 1 year.	1.2% 1/81 • Number of events 1 • AEs collected from enrollment through end of study which was a period of 1 year.
Investigations Blood Glucose Increased	0.00% 0/119 • AEs collected from enrollment through end of study which was a period of 1 year.	1.2% 1/81 • Number of events 1 • AEs collected from enrollment through end of study which was a period of 1 year.
Nervous system disorders Convulsion	0.84% 1/119 • Number of events 1 • AEs collected from enrollment through end of study which was a period of 1 year.	0.00% 0/81 • AEs collected from enrollment through end of study which was a period of 1 year.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.84% 1/119 • Number of events 1 • AEs collected from enrollment through end of study which was a period of 1 year.	0.00% 0/81 • AEs collected from enrollment through end of study which was a period of 1 year.
Gastrointestinal disorders Incisional hernia	1.7% 2/119 • Number of events 2 • AEs collected from enrollment through end of study which was a period of 1 year.	0.00% 0/81 • AEs collected from enrollment through end of study which was a period of 1 year.
Investigations Investigation	0.84% 1/119 • Number of events 1 • AEs collected from enrollment through end of study which was a period of 1 year.	0.00% 0/81 • AEs collected from enrollment through end of study which was a period of 1 year.
Metabolism and nutrition disorders Malnutrition	0.84% 1/119 • Number of events 1 • AEs collected from enrollment through end of study which was a period of 1 year.	0.00% 0/81 • AEs collected from enrollment through end of study which was a period of 1 year.
Investigations Oxygen saturation decreased	0.84% 1/119 • Number of events 1 • AEs collected from enrollment through end of study which was a period of 1 year.	0.00% 0/81 • AEs collected from enrollment through end of study which was a period of 1 year.
Gastrointestinal disorders Pain	0.00% 0/119 • AEs collected from enrollment through end of study which was a period of 1 year.	1.2% 1/81 • Number of events 1 • AEs collected from enrollment through end of study which was a period of 1 year.
Cardiac disorders Syncope	0.84% 1/119 • Number of events 3 • AEs collected from enrollment through end of study which was a period of 1 year.	0.00% 0/81 • AEs collected from enrollment through end of study which was a period of 1 year.
Respiratory, thoracic and mediastinal disorders Urinary Retention Postoperative	0.00% 0/119 • AEs collected from enrollment through end of study which was a period of 1 year.	2.5% 2/81 • Number of events 2 • AEs collected from enrollment through end of study which was a period of 1 year.
Renal and urinary disorders Urinary Tract infection	0.84% 1/119 • Number of events 1 • AEs collected from enrollment through end of study which was a period of 1 year.	0.00% 0/81 • AEs collected from enrollment through end of study which was a period of 1 year.