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ObesityGASTROMANCHNCT01539967

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

A study testing Laparoscopic Sleeve Gastrectomy in people with Obesity, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity
What is being tested?
Laparoscopic Sleeve Gastrectomy
Type of treatment
Surgery or procedure
How many people
90 participants
Where
1 siteFrance
Study dates
Aug 2009to Mar 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • older than 18 years old
  • laparoscopic Sleeve gastrectomy performed two years before
  • surgery performed in the digestive surgery department of the Amiens University Hospital

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

France1 site

  • Amiens University Hospital

    Amiens, 80054

Other trials in France

About this study

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

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.

Read the 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.
Conditions
Obesity
Being tested
Laparoscopic Sleeve Gastrectomy
Keywords
Laparoscopic Sleeve Gastrectomy, Obesity follow-up
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic Sleeve GastrectomyProcedure or surgery

    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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: during the consultation two years after the surgery

Secondary outcomes (1)

  1. 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

    Measured: two years after the surgical procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2012 (estimated)
  2. Study startAug 2009
  3. Primary completionMar 2011
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01539967
Sponsor's protocol ID
PI09-PR-REGIMBEAU
Other IDs
2009-A00603-54
Acronym
GASTROMANCH
Status last verified
Sep 2025
First submitted
7 Feb 2012
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
No

Publications

  • Pequignot A, Dhahria A, Mensah E, Verhaeghe P, Badaoui R, Sabbagh C, Regimbeau JM. Stapling and Section of the Nasogastric Tube during Sleeve Gastrectomy: How to Prevent and Recover? Case Rep Gastroenterol. 2011;5(2):350-4. doi: 10.1159/000329706. Epub 2011 Jul 6.

    PubMed 21769286

  • Dhahri A, Verhaeghe P, Hajji H, Fuks D, Badaoui R, Deguines JB, Regimbeau JM. Sleeve gastrectomy: technique and results. J Visc Surg. 2010 Oct;147(5 Suppl):e39-46. doi: 10.1016/j.jviscsurg.2010.08.016. No abstract available.

    PubMed 20971049

  • Sabbagh C, Verhaeghe P, Dhahri A, Brehant O, Fuks D, Badaoui R, Regimbeau JM. Two-year results on morbidity, weight loss and quality of life of sleeve gastrectomy as first procedure, sleeve gastrectomy after failure of gastric banding and gastric banding. Obes Surg. 2010 Jun;20(6):679-84. doi: 10.1007/s11695-009-0007-4. Epub 2009 Nov 10.

    PubMed 19902316

  • Fuks D, Verhaeghe P, Brehant O, Sabbagh C, Dumont F, Riboulot M, Delcenserie R, Regimbeau JM. Results of laparoscopic sleeve gastrectomy: a prospective study in 135 patients with morbid obesity. Surgery. 2009 Jan;145(1):106-13. doi: 10.1016/j.surg.2008.07.013. Epub 2008 Sep 30.

    PubMed 19081482

  • Fuks D, Dumont F, Berna P, Verhaeghe P, Sinna R, Sabbagh C, Demuynck F, Yzet T, Delcenserie R, Bartoli E, Regimbeau JM. Case report-complex management of a postoperative bronchogastric fistula after laparoscopic sleeve gastrectomy. Obes Surg. 2009 Feb;19(2):261-264. doi: 10.1007/s11695-008-9643-3. Epub 2008 Aug 12.

    PubMed 18696169

  • Deguines JB, Verhaeghe P, Yzet T, Robert B, Cosse C, Regimbeau JM. Is the residual gastric volume after laparoscopic sleeve gastrectomy an objective criterion for adapting the treatment strategy after failure? Surg Obes Relat Dis. 2013 Sep-Oct;9(5):660-6. doi: 10.1016/j.soard.2012.11.010. Epub 2013 Jan 17.

    PubMed 23452922

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic Sleeve Gastrectomy in people with Obesity, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

calculation of the BAROS Score (time frame: during the consultation two years after the surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01539967, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.

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