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Clinical Trials in France / NCT02937649
Recruiting Not applicable

Bougie Sleeve Trial

NCT02937649 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Not applicable
Started
2020-10-08
Last updated
2025-04-06

Condition(s) studied

Morbid Obesity

Investigational drug(s) / intervention(s)

Laparoscopic sleeve gastrectomy using 48-Fr bougieLaparoscopic sleeve gastrectomy using standard care bougie

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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * Patients between 18 and 70 years * Sleeve gastrectomy as a primary bariatric procedure * Body Mass Index (BMI) \> 40 kg/m² or \> 35 kg/m² associated with at least one comorbidity susceptible to improve after surgery (including arterial hypertension, obstructive sleep apnea syndrome and other severe respiratory disorders, severe metabolic disorders, particularly type 2 diabetes, incapacitating osteo-articular disorders, non alcoholic steatohepatitis) * Decision for intervention after multidisciplinary discussion * Written informed consent Exclusion Criteria: * Previous upper abdominal surgery (cholecystectomy excepted) * ASA (American Society of Anesthesiologists) score \> 3 * Ongoing pregnancy or breast feeding * Esophagus pathology or disorder (esophageal varices, esophageal diverticula, esophageal tumors, esophageal strictures) * Coagulation disorder * Patient not covered by social security service and patient on AME * Patient under legal guardianship and trusteeship * Patient with known silicon allergy (calibration bougie contains medical silicon) * More generally, all other contraindications to the use of esophageal bougie MID-TUBE that have been the subject of a scientific paper or have been identified by the practitioner or practitioners

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
Hôpital Ambroise Paré Boulogne-Billancourt France Suspended
Hôpital Côte de Nacre CHU de Caen Caen France Withdrawn
CHU Antoine Béclère Clamart France Recruiting
Centre hospitalier Intercommunal de Créteil Créteil France Withdrawn
Hôpital MICHALLON, CHU de Grenoble La Tronche France Withdrawn
Hôpital Dupuytren - Limoges Limoges France Withdrawn
Clinique de l'Yvette Longjumeau France Recruiting
Service de chirurgie générale et digestive, œsogastrique et bariatrique - Hôpital Bichat Paris France Recruiting
CHI - Centre Hospitalier Poissy/Saint-Germain-en-Laye Poissy France Recruiting
CH Saint-Denis Saint-Denis France Recruiting
Clinique Mutualiste Chirurgicale Saint-Etienne France Withdrawn
Hôpitaux de Brabois Vandœuvre-lès-Nancy France Recruiting

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Other trials for the same condition

Gastric Recalibration After Endoscopic Sleeve Gastroplasty Recruiting
Determinants of the Long-Term Success of Bariatric Surgery Recruiting
An Evaluation of the Outcomes of Bariatric Surgery - a Cohort Study Recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02937649 on ClinicalTrials.gov ↗ ← All trials in France