Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoing Robotic Assisted Gastric Bypass Surgery

Anastomotic leak rate over postoperative period

Number of patients having Anastomotic leak at each examination

Time frame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively

Anastomosis stenosis rate over postoperative period

Number of patients having Anastomosis stenosis at each examination

Time frame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively

Gastric fistula rate over postoperative period

Number of patients having Gastric fistula at each examination

Time frame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively

Rate of Obstruction over postoperative period

Number of patients having obstruction of the anastomosis at each examination

Time frame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively

Rate of Anastomosis bleeding over postoperative period

Number of patients having anastomosis bleeding at each examination

Time frame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively

Cumulative Frequency of other complications according to "Clavien-Dindo" over postoperative period

Number of other complications classified according to "Clavien-Dindo" classification in order to rank a complication in an objective and reproducible manner. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study. Complications that have the potential for long-lasting disability after patient's discharge (e.g.: paralysis of a voice cord after thyroid surgery) are highlighted in the present classification by a suffix ("d" for disability). This suffix indicates that a follow-up is required to comprehensively evaluate the outcome and related long-term quality of life

Time frame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively

Rate of Re-anastomosis over postoperative period

Number of re-anastomosis at each examination

Time frame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively

Total operation duration

time from cut to closure in minutes. The time is rounded up and only whole numbers are used

Time frame: intraoperatively

Total procedure costs

Costs (15 Euro / Operation minute; suture material, number of used sutures, costs / Hospital day)

Time frame: until discharge approximately 10 days after surgery

Length of postoperative stay

Number of days after surgery until the patient is discharged from hospital

Time frame: until discharge approximately 10 days after surgery

Patient satisfaction (VAS)

With the Visual Analogue Scale from 0 mm - 100 mm the satisfaction of the patient will be evaluated with 0 (not satisfied at all) to 100 (very satisfied).

Time frame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively

Patient pain (VAS)

With the Visual Analogue Scale from 0 mm - 100 mm the pain of the patient will be evaluated with 0 (no pain) to 100 (worst pain).

Time frame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively

Bariatric Analysis and Reporting Outcome System (BAROS)

questionnaire a common tool to evaluate patient's outcome and quality of life before and after bariatric surgeries. Three main parameters are evaluated with this tool, the weight, the medical conditions and the quality of life. The weight and the medical conditions will be evaluated by the physician. The questions regarding the quality of life will be answered directly by the patients. The six categories (felling, sexual activities, physical activities, work, food and social contacts) can be answered on scale with 10 steps from very good to very bad.

Time frame: preoperative, 30 days and 12 months post-surgery

Course of Health Status measured with EQ-5D-5L Score

EQ-5D-5L is a Quality of Life Score introduced by the EuroQol Group. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). Descriptive system comprises five dimensions (5D): mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels (5L): no problems, slight problems, moderate problems, severe problems, extreme problems. Each answer results in a 1-digit number. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.

Time frame: preoperative, 30 days and 12 months post-surgery

Assessment of the handling of the unidirectional barbed suture

intra-operatively including different dimensions with 5 evaluations levels (excellent, very good, good, satisfied, poor).

Time frame: intraoperatively

Assessment of the barbed suture compared to a conventional suture

Handling of barbed suture compared to a conventional suture (degree of difficulties and ease of handling) measured in two categories with a 5 point scale (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree)

Time frame: intraoperatively