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

Study Overview
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Brief Summary
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The study is designed as a prospective, mono-centric, randomized, patient blinded comparison of unidirectional barbed suture (Symmcora® mid term, UBS) vs. a conventional suture (Novosyn®, CS). Patient will be randomly allocated in a 1:1 ratio to either the UBS group or the CS group to perform the gastro-jejunal anastomosis (GJA) and the jejuno-jejunal anastomosis (JJA). The product under investigation and the conventional suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).

Official Title
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Prospective, Mono-center, Randomized, Single-blinded, Controlled Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoing Robotic Assisted Gastric Bypass Surgery

Conditions
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Adiposity

Intervention / Treatment
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* Device: Robotic assisted gastric bypass surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing an elective, primary robotic, assisted gastric bypass surgery (with a BMI ≥40 kg/m2 or with a BMI ≥35 kg/m2) with one or more of the following comorbidities: refractory arterial hypertension, type 2 diabetes mellitus and/or proven sleep apnea) with the need to close the gastro-jejunal anastomosis (GJA) and jejuno-jejunal anastomosis (JJA). Age ≥18 years Written informed consent Exclusion Criteria: Emergency surgery Previous gastric surgery History of chronic steroid use Pregnancy or breastfeeding Patients with hypersensitivity or allergy to the suture material Non compliance Participation in another randomized controlled trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| UBS<br>unidirectional barbed suture (Symmcora® mid term, UBS) | Device: Robotic assisted gastric bypass surgery<br>* The product under investigation and the conventional suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).<br>|
| CS<br>conventional suture (Novosyn®, CS) | Device: Robotic assisted gastric bypass surgery<br>* The product under investigation and the conventional suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to perform the anastomosis | Time to perform the gastro-jejunal anastomosis and the jejuno-jejunal anastomosis | intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomotic leak rate over postoperative period | Number of patients having Anastomotic leak at each examination | 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 | 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 | 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 | 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 | 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 | 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 | 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 | intraoperatively | 
| Total procedure costs | Costs (15 Euro / Operation minute; suture material, number of used sutures, costs / Hospital day) | until discharge approximately 10 days after surgery | 
| Length of postoperative stay | Number of days after surgery until the patient is discharged from hospital | 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). | 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). | 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. | 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'. | 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). | 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) | intraoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastro-jejunal anastomosis, jejuno-jejunal anastomosis, robotic assisted gastric bypass surgery