Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoing Robotic Assisted Gastric Bypass Surgery
- Conditions
- Adiposity
- Interventions
- Device: Robotic assisted gastric bypass surgery
- Registration Number
- NCT05433688
- Lead Sponsor
- Aesculap AG
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description UBS Robotic assisted gastric bypass surgery unidirectional barbed suture (Symmcora® mid term, UBS) CS Robotic assisted gastric bypass surgery conventional suture (Novosyn®, CS)
- Primary Outcome Measures
Name Time Method Time to perform the anastomosis intraoperatively Time to perform the gastro-jejunal anastomosis and the jejuno-jejunal anastomosis
- Secondary Outcome Measures
Name Time Method Anastomotic leak rate over postoperative period until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively Number of patients having Anastomotic leak at each examination
Rate of Anastomosis bleeding over postoperative period until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively Number of patients having anastomosis bleeding at each examination
Cumulative Frequency of other complications according to "Clavien-Dindo" over postoperative period until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively 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
Rate of Re-anastomosis over postoperative period until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively Number of re-anastomosis at each examination
Patient pain (VAS) until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively 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).
Assessment of the handling of the unidirectional barbed suture intraoperatively intra-operatively including different dimensions with 5 evaluations levels (excellent, very good, good, satisfied, poor).
Gastric fistula rate over postoperative period until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively Number of patients having Gastric fistula at each examination
Rate of Obstruction over postoperative period until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively Number of patients having obstruction of the anastomosis at each examination
Total operation duration intraoperatively time from cut to closure in minutes. The time is rounded up and only whole numbers are used
Bariatric Analysis and Reporting Outcome System (BAROS) preoperative, 30 days and 12 months post-surgery 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.
Anastomosis stenosis rate over postoperative period until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively Number of patients having Anastomosis stenosis at each examination
Length of postoperative stay until discharge approximately 10 days after surgery Number of days after surgery until the patient is discharged from hospital
Total procedure costs until discharge approximately 10 days after surgery Costs (15 Euro / Operation minute; suture material, number of used sutures, costs / Hospital day)
Patient satisfaction (VAS) until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively 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).
Course of Health Status measured with EQ-5D-5L Score preoperative, 30 days and 12 months post-surgery 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'.Assessment of the barbed suture compared to a conventional suture intraoperatively 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)
Trial Locations
- Locations (1)
Universitätsklinikum Schleswig-Holstein
🇩🇪Kiel, Schleswig-Holstein, Germany