Comparison of two types of sutures in robotic gastric bypass surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares the performance of Symmcora® mid-term suture and Novosyn® conventional suture in patients undergoing robotic-assisted gastric bypass surgery. It is a prospective, mono-centric, randomized, and patient-blinded trial where participants will be allocated to one of the two suture groups for the gastro-jejunal and jejuno-jejunal anastomoses. The goal is to evaluate the effectiveness and outcomes of these sutures in routine clinical practice.

Why it matters

Who can join: the full rules

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

Where it's running

• Universitätsklinikum Schleswig-Holstein
  Kiel, Schleswig-Holstein, Germany Recruiting

Study contacts

• Principal investigator: Jan H Beckmann, Dr. — University Hospital Schleswig-Holstein
• Study coordinator: Petra Baumann, Dr.
• Email: petra.baumann@aesculap.de
• Phone: +49746195

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.