Impact of the Residual Gastric Volume in Laparoscopic Sleeve Gastrectomy's Failure (GASTROMANCH)

September 16, 2025 updated by: Centre Hospitalier Universitaire, Amiens

Is the Residual Gastric Volume After Sleeve Gastrectomy an Objective Criterion to Adapt the Treatment Strategy After Failure?

Obesity is a worldwide health problematic whose incidence is increasing especially in developed countries. The surgical management of this illness consists in different techniques such as Laparoscopic Sleeve Gastrectomy but this treatment could not be efficient enough. The causes of failure after Laparoscopic Sleeve Gastrectomy are not known but could include the residual gastric volume.

The aim of the present study was to determine whether the residual gastric volume is involved in Laparoscopic Sleeve Gastrectomy's failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study can be done in three steps:

  1. From a prospective database, patients are selected if they were operated by Laparoscopic Sleeve gastrectomy at least two years before.
  2. these patients are convoked by their surgeon, who proposed them to participate at this study. During this consultation, the BAROS score is calculated by the surgeon and reported in the case report form of the patient.
  3. After checking the possible contraindication, a gastric computed tomography volumetry is done and the residual gastric volume is calculated by two independent radiologists.

Study Type

Interventional

Enrollment (Actual)

90

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 Locations

  • France
      • Amiens, France, 80054
        • Amiens University Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • older than 18 years old
  • laparoscopic Sleeve gastrectomy performed two years before
  • surgery performed in the digestive surgery department of the Amiens University Hospital

Exclusion Criteria:

  • pregnancy or breastfeeding
  • death of the patient or lost of follow-up
  • patient under legal or administrative protection
  • contraindication to the volumetry (pregnancy, technical impossibility)

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
calculation of the BAROS Score
Time Frame: during the consultation two years after the surgery
the BAROS Score is calculated by the surgeon and corresponds to the presence of a failure of Laparoscopic Sleeve Gastrectomy
during the consultation two years after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measure of the residual gastric volume by the radiologists
Time Frame: two years after the surgical procedure
the residual gastric volume is measured by gastric computed-tomography volumetry two years after Laparoscopic Sleeve Gastrectomy and is defined as the volume held between the gastro-oesophageal junction and the pylorus. Two radiologists interpreted the volumetry and conflicts between the 2 observers are resolved by consensus: the larger of each patient's two volume determinations was considered as being closest to the true residual gastric volume
two years after the surgical procedure

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Jean Marc REGIMBEAU, MD,phD, Amiens Universitary Hospital

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

August 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

February 7, 2012

First Submitted That Met QC Criteria

February 22, 2012

First Posted (Estimated)

February 28, 2012

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI09-PR-REGIMBEAU
  • 2009-A00603-54 (Other Identifier: ID-RCB)

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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