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

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ClinicalTrials.gov Identifier: NCT01539967
Recruitment Status : Completed
First Posted : February 28, 2012
Last Update Posted : April 6, 2012
Sponsor:
Information provided by (Responsible Party):

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
Obesity Procedure: Laparoscopic Sleeve Gastrectomy

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  (Clinical Trial)
Actual Enrollment : 90 participants
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 : August 2009
Primary Completion Date : March 2011
Study Completion Date : March 2011
Arms and Interventions

Intervention Details:
    Procedure: Laparoscopic Sleeve Gastrectomy

    the operative technique consists in few steps:

    • position of 4 trocars and insertion of a nasogastric tube
    • dissection and mobilization of the greater curvature of the stomach
    • preparation of the stomach for division
    • gastric partition
    • extraction of the gastric remnant
    • postoperative surveillance

Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539967


Locations
France
Amiens University Hospital
Amiens, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Principal Investigator: Jean Marc REGIMBEAU, MD,phD Amiens Universitary Hospital
More Information

Publications:
Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01539967     History of Changes
Other Study ID Numbers: PI09-PR-REGIMBEAU
2009-A00603-54 ( Other Identifier: ID-RCB )
First Posted: February 28, 2012    Key Record Dates
Last Update Posted: April 6, 2012
Last Verified: April 2012

Keywords provided by Centre Hospitalier Universitaire, Amiens:
Laparoscopic Sleeve Gastrectomy
Obesity follow-up