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Bougie Sleeve Trial (BOUST)

Primary Purpose

Morbid Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Laparoscopic sleeve gastrectomy using 48-Fr bougie
Laparoscopic sleeve gastrectomy using standard care bougie
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Obesity, Bariatric surgery, Sleeve gastrectomy, Staple-line Leak, Bougie, Calibration

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Ambroise Paré
  • Hôpital Côte de Nacre CHU de Caen
  • CHU Antoine Béclère
  • Centre hospitalier Intercommunal de Créteil
  • Hôpital MICHALLON, CHU de Grenoble
  • Hôpital Dupuytren - Limoges
  • Clinique de l'Yvette
  • Service de chirurgie générale et digestive, œsogastrique et bariatrique - Hôpital Bichat
  • CHI - Centre Hospitalier Poissy/Saint-Germain-en-Laye
  • CH Saint-Denis
  • Clinique Mutualiste Chirurgicale
  • Hôpitaux de Brabois

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic sleeve gastrectomy using 48-Fr bougie

Laparoscopic sleeve gastrectomy using standard care bougie

Arm Description

Patients will undergo laparoscopic sleeve gastrectomy with a 48-Fr (16 mm) bougie

Patients will undergo laparoscopic sleeve gastrectomy with a standard care bougie (34, 36 or 38-Fr)

Outcomes

Primary Outcome Measures

Postoperative gastric leak rate
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

Secondary Outcome Measures

Postoperative morbidity rate
Postoperative morbidity rate will be calculated regarding any complication occurring 90 days following the procedure.
Short-term weight loss
Short-term weight loss will be assessed by calculation of excess weight loss at 3 and 6 months after the procedure.
Mid-term weight loss
Mid-term weight loss will be assessed by calculation of excess weight loss at 1 and 2 years after the procedure.
Quality of life related to health
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)

Full Information

First Posted
October 17, 2016
Last Updated
August 17, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02937649
Brief Title
Bougie Sleeve Trial
Acronym
BOUST
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 20, 2020 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Obesity, Bariatric surgery, Sleeve gastrectomy, Staple-line Leak, Bougie, Calibration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1658 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic sleeve gastrectomy using 48-Fr bougie
Arm Type
Experimental
Arm Description
Patients will undergo laparoscopic sleeve gastrectomy with a 48-Fr (16 mm) bougie
Arm Title
Laparoscopic sleeve gastrectomy using standard care bougie
Arm Type
Active Comparator
Arm Description
Patients will undergo laparoscopic sleeve gastrectomy with a standard care bougie (34, 36 or 38-Fr)
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic sleeve gastrectomy using 48-Fr bougie
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic sleeve gastrectomy using standard care bougie
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative gastric leak rate
Description
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
Time Frame
30 days following the procedure
Secondary Outcome Measure Information:
Title
Postoperative morbidity rate
Description
Postoperative morbidity rate will be calculated regarding any complication occurring 90 days following the procedure.
Time Frame
90 days following the procedure
Title
Short-term weight loss
Description
Short-term weight loss will be assessed by calculation of excess weight loss at 3 and 6 months after the procedure.
Time Frame
At 3 and 6 months after the procedure
Title
Mid-term weight loss
Description
Mid-term weight loss will be assessed by calculation of excess weight loss at 1 and 2 years after the procedure.
Time Frame
At 1 and 2 years after the procedure
Title
Quality of life related to health
Description
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)
Time Frame
At 3 months, 6 months, 1 year and 2 years after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hadrien TRANCHART, Dr
Phone
(+33)145374037
Email
hadrien.tranchart@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Ibrahim DAGHER, Pr
Phone
(+33)145374143
Email
ibrahim.dagher@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadrien TRANCHART, Dr
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Ambroise Paré
City
Boulogne-Billancourt
ZIP/Postal Code
92104
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karina VYCHNEVSKAIA, Dr
Facility Name
Hôpital Côte de Nacre CHU de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud ALVES, Pr
Facility Name
CHU Antoine Béclère
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hadrien TRANCHART, Dr
Email
hadrien.tranchart@aphp.fr
Facility Name
Centre hospitalier Intercommunal de Créteil
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea LAZZATI, Dr
Facility Name
Hôpital MICHALLON, CHU de Grenoble
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Hôpital Dupuytren - Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Clinique de l'Yvette
City
Longjumeau
ZIP/Postal Code
91120
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aziz KARAA, Dr
Facility Name
Service de chirurgie générale et digestive, œsogastrique et bariatrique - Hôpital Bichat
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionel REBIBO, Dr
Facility Name
CHI - Centre Hospitalier Poissy/Saint-Germain-en-Laye
City
Poissy
ZIP/Postal Code
78300
Country
France
Facility Name
CH Saint-Denis
City
Saint-Denis
ZIP/Postal Code
93200
Country
France
Facility Name
Clinique Mutualiste Chirurgicale
City
Saint-Étienne
ZIP/Postal Code
42100
Country
France
Facility Name
Hôpitaux de Brabois
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34781991
Citation
Gaillard M, Lainas P, Agostini H, Dagher I, Tranchart H. Impact of the calibration bougie diametre during laparoscopic sleeve gastrectomy on the rate of postoperative staple-line leak (BOUST): study protocol for a multicentre randomized prospective trial. Trials. 2021 Nov 15;22(1):806. doi: 10.1186/s13063-021-05734-3.
Results Reference
derived

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Bougie Sleeve Trial

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