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Search / Trial NCT05433688

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

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Gastro Jejunal Anastomosis Jejuno Jejunal Anastomosis Robotic Assisted Gastric Bypass Surgery

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

About Aesculap Ag

Aesculap AG is a prominent global medical device manufacturer specializing in surgical instruments, implants, and innovative healthcare solutions. With a rich history rooted in excellence and innovation, Aesculap AG is dedicated to advancing surgical practices through cutting-edge technology and a commitment to improving patient outcomes. The company collaborates with healthcare professionals and institutions to conduct clinical trials that evaluate the safety and efficacy of its products, ensuring that they meet the highest standards of quality and performance. Through its rigorous research and development initiatives, Aesculap AG aims to contribute significantly to the field of medicine and enhance the standards of surgical care worldwide.

Locations

Kiel, Schleswig Holstein, Germany

Patients applied

0 patients applied

Trial Officials

Jan H Beckmann, Dr.

Principal Investigator

University Hospital Schleswig-Holstein

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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