Bougie Sleeve Trial

Last updated: April 4, 2025
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Treatment

Laparoscopic sleeve gastrectomy using standard care bougie

Laparoscopic sleeve gastrectomy using 48-Fr bougie

Clinical Study ID

NCT02937649
P150933
  • Ages 18-70
  • All Genders

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 Criteria

Inclusion

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 onecomorbidity susceptible to improve after surgery (including arterial hypertension,obstructive sleep apnea syndrome and other severe respiratory disorders, severemetabolic disorders, particularly type 2 diabetes, incapacitating osteo-articulardisorders, non alcoholic steatohepatitis)

  • Decision for intervention after multidisciplinary discussion

  • Written informed consent

Exclusion

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-TUBEthat have been the subject of a scientific paper or have been identified by thepractitioner or practitioners

Study Design

Total Participants: 1658
Treatment Group(s): 2
Primary Treatment: Laparoscopic sleeve gastrectomy using standard care bougie
Phase:
Study Start date:
October 08, 2020
Estimated Completion Date:
September 08, 2027

Study 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 result in long and incapacitating treatment. The diameter of the bougie used to calibrate the remnant stomach could impact the rate of gastric leak, a higher diameter being correlated with a lower risk of leak, without lowering long-term weight loss.

The aim of this prospective randomized trial is to compare the outcomes of LSG according to the use of a standard care bougie calibre or 48-Fr on postoperative gastric leak and mid-term weight loss.

Connect with a study center

  • Hôpital Ambroise Paré

    Boulogne-Billancourt, 92104
    France

    Suspended

  • Hôpital Côte de Nacre CHU de Caen

    Caen, 14033
    France

    Site Not Available

  • CHU Antoine Béclère

    Clamart, 92140
    France

    Active - Recruiting

  • Centre hospitalier Intercommunal de Créteil

    Créteil, 94010
    France

    Site Not Available

  • Hôpital MICHALLON, CHU de Grenoble

    La Tronche, 38700
    France

    Site Not Available

  • Hôpital Dupuytren - Limoges

    Limoges, 87042
    France

    Site Not Available

  • Clinique de l'Yvette

    Longjumeau, 91120
    France

    Active - Recruiting

  • Service de chirurgie générale et digestive, œsogastrique et bariatrique - Hôpital Bichat

    Paris, 75018
    France

    Active - Recruiting

  • CHI - Centre Hospitalier Poissy/Saint-Germain-en-Laye

    Poissy, 78300
    France

    Active - Recruiting

  • CH Saint-Denis

    Saint-Denis, 93200
    France

    Active - Recruiting

  • Clinique Mutualiste Chirurgicale

    Saint-Étienne, 42100
    France

    Site Not Available

  • Hôpitaux de Brabois

    Vandœuvre-lès-Nancy, 54500
    France

    Active - Recruiting

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