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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01539967
Acronym
GASTROMANCH
Enrollment
90
Registered
2012-02-28
Start date
2009-08-31
Completion date
2011-03-31
Last updated
2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Laparoscopic Sleeve Gastrectomy, Obesity follow-up

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.

Interventions

PROCEDURELaparoscopic 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

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
calculation of the BAROS Scoreduring the consultation two years after the surgerythe BAROS Score is calculated by the surgeon and corresponds to the presence of a failure of Laparoscopic Sleeve Gastrectomy

Secondary

MeasureTime frameDescription
measure of the residual gastric volume by the radiologiststwo years after the surgical procedurethe 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026