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Bougie Sleeve Trial — BOUST  

Morbid Obesity Clinical Trial

Official title:
Multicentric Randomized Prospective Study Assessing the Impact of the Bougie Calibration Size During Laparoscopic Sleeve Gastrectomy on the Rate of Postoperative Staple-line Leak Rate

Clinical Trial Summary

Staple-line leak is the most frequent and incapacitating complication after laparoscopic sleeve gastrectomy (LSG). The aim of this prospective randomized trial is to compare the staple-line leak rate after LSG according to the use of a standard bougie calibre (34, 36 or 38 Fr) or 48-Fr, assuming that a higher diameter is correlated with a lower risk of leak, without lowering long-term weight loss.

Clinical Trial Description

Laparoscopic sleeve gastrectomy (LSG) has become an increasing bariatric procedure. The most common complication is gastric leak from the staple line, observed in approximately 3% of cases, and can result in long and incapacitating treatment. The diameter of the bougie used to calibrate the remnant stomach could impact the rate of gastric leak, a higher diameter being correlated with a lower risk of leak, without lowering long-term weight loss.

The aim of this prospective randomized trial is to compare the outcomes of LSG according to the use of a standard care bougie calibre or 48-Fr on postoperative gastric leak and mid-term weight loss. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02937649
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Hadrien TRANCHART, Dr
Phone (+33)145374037
Email hadrien.tranchart@aphp.fr
Status Not yet recruiting
Phase N/A
Start date September 20, 2020
Completion date December 2024
View Details
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