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RECRUITING
NCT02937649
NA

Bougie Sleeve Trial

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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

PROCEDURE

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.

PROCEDURE

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