Impact of the Residual Gastric Volume in Laparoscopic Sleeve Gastrectomy's Failure (GASTROMANCH)
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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?|
- calculation of the BAROS Score [ Time Frame: during the consultation two years after the surgery ] [ Designated as safety issue: No ]the BAROS Score is calculated by the surgeon and corresponds to the presence of a failure of Laparoscopic Sleeve Gastrectomy
- measure of the residual gastric volume by the radiologists [ Time Frame: two years after the surgical procedure ] [ Designated as safety issue: No ]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
|Study Start Date:||August 2009|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Procedure: Laparoscopic Sleeve Gastrectomy
- 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
the operative technique consists in few steps:
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539967
|Amiens University Hospital|
|Amiens, France, 80054|
|Principal Investigator:||Jean Marc REGIMBEAU, MD,phD||Amiens Universitary Hospital|