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

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).

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