NCT01539967

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 28, 2012

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

1.6 years

First QC Date

February 7, 2012

Last Update Submit

September 16, 2025

Conditions

Obesity

Keywords

Laparoscopic Sleeve GastrectomyObesity follow-up

Outcome Measures

Primary Outcomes (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

    during the consultation two years after the surgery

Secondary Outcomes (1)

  • measure of the residual gastric volume by the radiologists

    two years after the surgical procedure

Interventions

Laparoscopic Sleeve GastrectomyPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amiens University Hospital

Amiens, 80054, France

Location

Related Publications (6)

  • 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.

    PMID: 21769286BACKGROUND

  • 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.

    PMID: 20971049BACKGROUND

  • 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.

    PMID: 19902316BACKGROUND

  • 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.

    PMID: 19081482BACKGROUND

  • 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.

    PMID: 18696169BACKGROUND

  • 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.

    PMID: 23452922RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jean Marc REGIMBEAU, MD,phD

    Amiens Universitary Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2012

First Posted

February 28, 2012

Study Start

August 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations

FR(1)