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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
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.
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.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Hôpital Ambroise Paré
Boulogne-Billancourt, France
Hôpital Côte de Nacre CHU de Caen
Caen, France
CHU Antoine Béclère
Clamart, France
Centre hospitalier Intercommunal de Créteil
Créteil, France
Hôpital MICHALLON, CHU de Grenoble
La Tronche, France
Hôpital Dupuytren - Limoges
Limoges, France
Clinique de l'Yvette
Longjumeau, France
Service de chirurgie générale et digestive, œsogastrique et bariatrique - Hôpital Bichat
Paris, France
CHI - Centre Hospitalier Poissy/Saint-Germain-en-Laye
Poissy, France
CH Saint-Denis
Saint-Denis, France
Start Date
October 8, 2020
Primary Completion Date
June 8, 2025
Completion Date
September 8, 2027
Last Updated
April 6, 2025
1,658
ESTIMATED participants
Laparoscopic sleeve gastrectomy using 48-Fr bougie
PROCEDURE
Laparoscopic sleeve gastrectomy using standard care bougie
PROCEDURE
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07461610