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Bougie Sleeve Trial

NCT02937649 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1658

Last updated 2025-04-06

No results posted yet for this study

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.

Conditions

  • Morbid Obesity

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.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Hadrien TRANCHART, Dr · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-08
Primary Completion
2025-06-08
Completion
2027-09-08

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02937649 on ClinicalTrials.gov