NCT02937649

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,658

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Oct 2020Sep 2027

First Submitted

Initial submission to the registry

October 17, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
4 years until next milestone

Study Start

First participant enrolled

October 8, 2020

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2025

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2027

Expected
Last Updated

April 6, 2025

Status Verified

March 1, 2025

Enrollment Period

4.7 years

First QC Date

October 17, 2016

Last Update Submit

April 4, 2025

Conditions

Morbid Obesity

Keywords

ObesityBariatric surgerySleeve gastrectomyStaple-line LeakBougieCalibration

Outcome Measures

Primary Outcomes (1)

  • 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

    30 days following the procedure

Secondary Outcomes (4)

  • Postoperative morbidity rate

    90 days following the procedure

  • Short-term weight loss

    At 3 and 6 months after the procedure

  • Mid-term weight loss

    At 1 and 2 years after the procedure

  • Quality of life related to health

    At 3 months, 6 months, 1 year and 2 years after the procedure

Study Arms (2)

Laparoscopic sleeve gastrectomy using 48-Fr bougie

EXPERIMENTAL

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

Procedure: Laparoscopic sleeve gastrectomy using 48-Fr bougie

Laparoscopic sleeve gastrectomy using standard care bougie

ACTIVE COMPARATOR

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

Procedure: Laparoscopic sleeve gastrectomy using standard care bougie

Interventions

Laparoscopic sleeve gastrectomy using 48-Fr bougiePROCEDURE

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 48-Fr bougie
Laparoscopic sleeve gastrectomy using standard care bougiePROCEDURE

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.

Laparoscopic sleeve gastrectomy using standard care bougie

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Hôpital Ambroise Paré

Boulogne-Billancourt, 92104, France

SUSPENDED

Hôpital Côte de Nacre CHU de Caen

Caen, 14033, France

WITHDRAWN

CHU Antoine Béclère

Clamart, 92140, France

RECRUITING

Centre hospitalier Intercommunal de Créteil

Créteil, 94010, France

WITHDRAWN

Hôpital MICHALLON, CHU de Grenoble

La Tronche, 38700, France

WITHDRAWN

Hôpital Dupuytren - Limoges

Limoges, 87042, France

WITHDRAWN

Clinique de l'Yvette

Longjumeau, 91120, France

RECRUITING

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

Paris, 75018, France

RECRUITING

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

Poissy, 78300, France

RECRUITING

CH Saint-Denis

Saint-Denis, 93200, France

RECRUITING

Clinique Mutualiste Chirurgicale

Saint-Etienne, 42100, France

WITHDRAWN

Hôpitaux de Brabois

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34781991DERIVED

MeSH Terms

Conditions

Obesity, MorbidObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hadrien TRANCHART, Dr

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hadrien TRANCHART, Dr

CONTACT

(+33)145374037hadrien.tranchart@aphp.fr

Ibrahim DAGHER, Pr

CONTACT

(+33)145374143ibrahim.dagher@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 18, 2016

Study Start

October 8, 2020

Primary Completion

June 8, 2025

Study Completion (Estimated)

September 8, 2027

Last Updated

April 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(12)