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

Adiposity Clinical Trial

— BARGASTRO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05433688
• Other study ID #: AAG-O-H-1932
• Status: Recruiting
• Start date: October 12, 2022
• Est. completion date: July 2025

Study information

• Verified date: October 2023
• Source: Aesculap AG
• Contact: Petra Baumann, Dr.
• Phone: +49746195
• Email: petra.baumann[@]aesculap.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adiposity
• Obesity

Intervention

Device:
• Robotic assisted gastric bypass surgery
The product under investigation and the conventional suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).

Locations

Country	Name	City	State
Germany	Universitätsklinikum Schleswig-Holstein	Kiel	Schleswig-Holstein

Sponsors (2)

Lead Sponsor	Collaborator
Aesculap AG	B.Braun Surgical SA

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to perform the anastomosis	Time to perform the gastro-jejunal anastomosis and the jejuno-jejunal anastomosis	intraoperatively
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Total operation duration	time from cut to closure in minutes. The time is rounded up and only whole numbers are used	intraoperatively
Secondary	Total procedure costs	Costs (15 Euro / Operation minute; suture material, number of used sutures, costs / Hospital day)	until discharge approximately 10 days after surgery
Secondary	Length of postoperative stay	Number of days after surgery until the patient is discharged from hospital	until discharge approximately 10 days after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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