Status:
ACTIVE_NOT_RECRUITING
Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoing Robotic Assisted Gastric Bypass Surgery
Lead Sponsor:
Aesculap AG
Collaborating Sponsors:
B.Braun Surgical SA
Conditions:
Adiposity
Eligibility:
All Genders
18+ years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 12 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05433688
Start Date
October 12 2022
End Date
January 1 2027
Last Update
August 13 2025
Active Locations (1)
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1
Universitätsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany, 24105