+1 877 705 191424 / 7
HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID02937649

Study Comparing Different Bougie Sizes During Laparoscopic Sleeve Gastrectomy to Reduce Postoperative Staple-line Leaks and Maintain Weight Loss

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-04-06

1658

Participants Needed

12

Research Sites

117 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating how the size of the bougie used during laparoscopic sleeve gastrectomy LSG affects the rate of postoperative stomach leaks, which is the most common and serious complication after this weight loss surgery. This prospective randomized trial compares the use of a larger 48-Fr bougie to standard smaller bougie sizes 34, 36, or 38 Fr to see if a bigger diameter lowers leak risk without reducing long-term weight loss. Participants will undergo laparoscopic sleeve gastrectomy using either the 48-Fr bougie or a standard care bougie. The bougie is inserted through the mouth by the anesthesiologist and positioned in the stomach before the gastrectomy is performed alongside it. Patients do not know which bougie size they receive. This study aims to assess differences in leak rates and weight loss outcomes between the two bougie sizes. During the study, researchers will monitor participants for stomach leaks within 30 days after surgery as the primary outcome. Secondary outcomes include complications within 90 days, weight loss at 3, 6, 12, and 24 months, and quality of life up to 2 years. Participants will have follow-up visits for these assessments to track recovery, safety, and weight changes over time.

CONDITIONS

Brief Title

Bougie Sleeve Trial

Research Team

H

Hadrien TRANCHART, Dr

I

Ibrahim DAGHER, Pr

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here