Actively Recruiting
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
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