Bougie Sleeve Trial (BOUST)

August 17, 2020 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Anticipated)

1658

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Boulogne-Billancourt, France, 92104
        • Hopital Ambroise Pare
        • Contact:
          • Karina VYCHNEVSKAIA, Dr
      • Caen, France, 14033
        • Hôpital Côte de Nacre CHU de Caen
        • Contact:
          • Arnaud ALVES, Pr
      • Clamart, France, 92140
      • Créteil, France, 94010
        • Centre Hospitalier Intercommunal de Créteil
        • Contact:
          • Andrea LAZZATI, Dr
      • La Tronche, France, 38700
        • Hôpital Michallon, CHU de Grenoble
      • Limoges, France, 87042
        • HOPITAL DUPUYTREN - LIMOGES
      • Longjumeau, France, 91120
        • Clinique de L'Yvette
        • Contact:
          • Aziz KARAA, Dr
      • Paris, France, 75018
        • Service de chirurgie générale et digestive, œsogastrique et bariatrique - Hôpital Bichat
        • Contact:
          • Lionel REBIBO, Dr
      • Poissy, France, 78300
        • CHI - Centre Hospitalier Poissy/Saint-Germain-en-Laye
      • Saint-Denis, France, 93200
        • CH Saint-Denis
      • Saint-Étienne, France, 42100
        • Clinique Mutualiste Chirurgicale
      • Vandœuvre-lès-Nancy, France, 54500
        • Hopitaux De Brabois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laparoscopic sleeve gastrectomy using 48-Fr bougie
Patients will undergo laparoscopic sleeve gastrectomy with a 48-Fr (16 mm) bougie
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.
Active Comparator: Laparoscopic sleeve gastrectomy using standard care bougie
Patients will undergo laparoscopic sleeve gastrectomy with a standard care bougie (34, 36 or 38-Fr)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative gastric leak rate
Time Frame: 30 days following the procedure

Postoperative gastric leak rate during the first month following the procedure will be proven either on:

  • Morphologic examination (with contrast ingestion)
  • Blue dye test during surgical reintervention or postoperative course
  • Contrast opacification during endoscopy
30 days following the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative morbidity rate
Time Frame: 90 days following the procedure
Postoperative morbidity rate will be calculated regarding any complication occurring 90 days following the procedure.
90 days following the procedure
Short-term weight loss
Time Frame: At 3 and 6 months after the procedure
Short-term weight loss will be assessed by calculation of excess weight loss at 3 and 6 months after the procedure.
At 3 and 6 months after the procedure
Mid-term weight loss
Time Frame: At 1 and 2 years after the procedure
Mid-term weight loss will be assessed by calculation of excess weight loss at 1 and 2 years after the procedure.
At 1 and 2 years after the procedure
Quality of life related to health
Time Frame: At 3 months, 6 months, 1 year and 2 years after the procedure
Quality of life related to health will be assessed at 3 months, 6 months, 1 year and 2 years after the procedure with the validated GIQLI scale (Gastro Intestinal Quality of Life Index)
At 3 months, 6 months, 1 year and 2 years after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Hadrien TRANCHART, Dr, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 20, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

October 17, 2016

First Submitted That Met QC Criteria

October 17, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Actual)

August 18, 2020

Last Update Submitted That Met QC Criteria

August 17, 2020

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P150933

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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