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

C

Centre Hospitalier Universitaire, Amiens

Status

Completed

Conditions

Obesity

Treatments

Procedure: Laparoscopic Sleeve Gastrectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT01539967
PI09-PR-REGIMBEAU
2009-A00603-54 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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