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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Adiposity
• Intervention / Treatment: Device: Robotic assisted gastric bypass surgery

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Germany
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Universitatsklinikum Schleswig-Holstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients undergoing elective primary, robotic assisted gastric bypass surgery with the need to close the gastro-jejunal anastomosis and the jejuno-jejunal anastomosis.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
UBS; unidirectional barbed suture (Symmcora® mid term, UBS)	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).
CS; conventional suture (Novosyn®, CS)	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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aesculap AG
• Collaborators: B.Braun Surgical SA
• Investigators: Principal Investigator: Jan H Beckmann, Dr., University Hospital Schleswig-Holstein

Publications and helpful links

General Publications

• Beckmann JH, Baumann P, Jackisch C, Richter F, Mehdorn AS, Becker T, Taivankhuu T, von Schonfels W. Assessment of a new unidirectional barbed suture versus a conventional suture for anastomosis during robotic-assisted Roux-en-Y gastric bypass surgery in obese patients: BARGASTRO - study protocol for a German randomized active-controlled trial. Trials. 2026 Jan 6;27(1):87. doi: 10.1186/s13063-025-09401-9.

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: gastro-jejunal anastomosis; jejuno-jejunal anastomosis; robotic assisted gastric bypass surgery
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: AAG-O-H-1932

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No