NCT05433688Completed

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

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

Source: ClinicalTrials.gov · Last updated 29 Jun 2026

Brief summary (registry, in English)

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).

Status (registry): Completed
Study type: Observational
Enrollment: 150 (actual)
First submitted: 22 Jun 2022
Start date: 12 Oct 2022
Primary completion date: 11 Mar 2026
Lead sponsor: Aesculap AG
NCT number: NCT05433688

What you commit to

Study type: Observational
Participants enrolled: 150
From 12 Oct 2022 to the primary completion date, 11 Mar 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Emergency surgery
Previous gastric surgery

Other illness

History of chronic steroid use
Patients with hypersensitivity or allergy to the suture material

Other

Pregnancy or breastfeeding
Non compliance
Participation in another randomized controlled trial

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Universitatsklinikum Schleswig-Holstein Coordinator of this site? Confirm its status	Kiel	Germany	Unknown status

Related publications

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 · PMID 41495768

This page is information, not medical advice. Discuss any trial with your doctor.