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

Study Overview
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Brief Summary
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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
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This study can be done in three steps: From a prospective database, patients are selected if they were operated by Laparoscopic Sleeve gastrectomy at least two years before. 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. After checking the possible contraindication, a gastric computed tomography volumetry is done and the residual gastric volume is calculated by two independent radiologists.

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

Conditions
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Obesity

Intervention / Treatment
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* Procedure: Laparoscopic Sleeve Gastrectomy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| calculation of the BAROS Score | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic Sleeve Gastrectomy, Obesity follow-up