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

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT01539967
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

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 Timeline

• Study Start: 2009-08
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Study First Submitted: 2012-02-07
• Study First Submitted QC: 2012-02-22
• Study First Posted: 2012-02-28
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-05
• Last Update Posted: 2012-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Amiens University Hospital; 🇫🇷 Amiens, France