NCT04613635

Stratafix vs. Vicryl OAGB / MGB Suture Study

Comparison of 2 Suture Materials for Closure of Ventral Defect at the Gastrojejunostomy in One-Anastomosis-Gastric Bypass / Mini-Gastric Bypass (OAGB / MGB): a Randomized Short Term Study With Monocrylic Spiral Knotless Tissue Control Device vs. Traditional Polyglactin Multifilament Suture

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: St. Franziskus Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare shorttime (6 months) results of two competitive suture materials with regard to time demanded to perform the concerned surgical step and secondary to study anastomotic site safety and complications like leakage and hemorrhage as well as development of anastomotic strictures. Evaluation of cost-effectiveness.

Conditions

• Morbid Obesity
• Anastomotic Leak
• Anastomotic Stenosis
• Hemorrhage Postoperative

Interventions

Type	Name	Description
DEVICE	Stratafix	Closure of ventral defect of the otherwise stapled gastrojejunal anastomosis with Stratafix USP (United States Pharmacopoe) 2-0 thread
DEVICE	Vicryl	Closure of ventral defect of the otherwise stapled gastrojejunal anastomosis with Vicryl USP 2-0 thread

Timeline

• Start date: 2020-11-06
• Primary completion: 2023-10-27
• Completion: 2024-04-30
• First posted: 2020-11-03
• Last updated: 2024-12-17

Locations

1 site across 1 country: Germany