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

Launched by AESCULAP AG · Jun 22, 2022

Keywords

ClinConnect Summary

This clinical trial is comparing two types of sutures used during robotic-assisted gastric bypass surgery. The study is specifically looking at a new unidirectional barbed suture called Symmcora® mid-term suture and a conventional suture called Novosyn®. The goal is to see which suture performs better when closing two important connections in the digestive system after surgery. Participants will be randomly assigned to receive either the new suture or the conventional one, and they will not know which one they received.

To be eligible for the trial, participants need to be at least 18 years old and planning to have elective gastric bypass surgery. They should have a body mass index (BMI) of 35 or higher, especially if they also have health conditions like high blood pressure, type 2 diabetes, or sleep apnea. Those who have had previous stomach surgeries, are pregnant or breastfeeding, or have certain allergies or health issues are not eligible. Participants can expect to receive standard care for their surgery, and their involvement will help researchers learn more about the effectiveness of these sutures in improving surgical outcomes.

Gender

ALL

Eligibility criteria

• 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