Clinical Research Directory
Browse clinical research sites, groups, and studies.
Bougie Sleeve Trial
Sponsor: Assistance Publique - Hôpitaux de Paris
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.
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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
1658
Start Date
2020-10-08
Completion Date
2027-09-08
Last Updated
2025-04-06
Healthy Volunteers
No
Conditions
Interventions
Laparoscopic sleeve gastrectomy using 48-Fr bougie
After gastric mobilization, the 48-Fr bougie is inserted through the mouth by the anesthesiologist and positioned in the stomach. Patient is blind to the type of bougie used. Gastrectomy is performed alongside the calibration bougie.
Laparoscopic sleeve gastrectomy using standard care bougie
After gastric mobilization, the standard care bougie is inserted through the mouth by the anesthesiologist and positioned in the stomach. Patient is blind to the type of bougie used. Gastrectomy is performed alongside the calibration bougie.
Locations (12)
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
Clinique Mutualiste Chirurgicale
Saint-Etienne, France
Hôpitaux de Brabois
Vandœuvre-lès-Nancy, France