Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoing Robotic Assisted Gastric Bypass Surgery (BARGASTRO)
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Details and patient eligibility
About
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).
Enrollment
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Volunteers
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
Trial design
150 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Petra Baumann, Dr.
Data sourced from clinicaltrials.gov
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