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

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Completed
CT.gov ID
NCT01539967
Collaborator
(none)
90
1
19
4.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Laparoscopic Sleeve Gastrectomy
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Is the Residual Gastric Volume After Sleeve Gastrectomy an Objective Criterion to Adapt the Treatment Strategy After Failure?
Study Start Date :
Aug 1, 2009
Actual Primary Completion Date :
Mar 1, 2011
Actual Study Completion Date :
Mar 1, 2011

Outcome Measures

Primary Outcome Measures

  1. calculation of the BAROS Score [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

Secondary Outcome Measures

  1. measure of the residual gastric volume by the radiologists [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Amiens University Hospital Amiens France 80054

Sponsors and Collaborators

  • Centre Hospitalier Universitaire, Amiens

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT01539967
Other Study ID Numbers:
  • PI09-PR-REGIMBEAU
  • 2009-A00603-54
First Posted:
Feb 28, 2012
Last Update Posted:
Apr 6, 2012
Last Verified:
Apr 1, 2012
Keywords provided by Centre Hospitalier Universitaire, Amiens
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2012