Status:

RECRUITING

Bougie Sleeve Trial

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Conditions:

Morbid Obesity

Eligibility:

All Genders

18-70 years

Phase:

NA

Brief 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 ...

Detailed Description

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 re...

Eligibility Criteria

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

Key Trial Info

Start Date :

October 8 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 8 2027

Estimated Enrollment :

1658 Patients enrolled

Trial Details

Trial ID

NCT02937649

Start Date

October 8 2020

End Date

September 8 2027

Last Update

April 6 2025

Active Locations (12)

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Page 1 of 3 (12 locations)

1

Hôpital Ambroise Paré

Boulogne-Billancourt, France, 92104

2

Hôpital Côte de Nacre CHU de Caen

Caen, France, 14033

3

CHU Antoine Béclère

Clamart, France, 92140

4

Centre hospitalier Intercommunal de Créteil

Créteil, France, 94010