NCT01513005

Brief Summary

The aim of this study is to determinate the feasibility of the Laparoscopic Sleeve Gastrectomy, a bariatric surgery i.e. a surgery as a treatment for obesity, could be proposed as a Day-Case surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started May 2011

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

May 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

January 16, 2012

Last Update Submit

September 16, 2025

Conditions

Obesity

Keywords

Laparoscopic Sleeve Gastrectomyobesity management

Outcome Measures

Primary Outcomes (1)

  • unexpected admission rate

    the unexpected admission rate corresponds to the number of overnight hospitalization i.e. the number of patients not treated considering a Day-Case Surgery.

    the day following the surgery

Secondary Outcomes (7)

  • readmission rate

    one year

  • unexpected consultation rate

    one year

  • reoperation rate

    one year

  • overall length of stay

    one year

  • per operative outcomes

    one year

  • +2 more secondary outcomes

Study Arms (1)

Laparoscopic Sleeve Gastrectomy

EXPERIMENTAL
Procedure: Laparoscopic Sleeve Gastrectomy

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

Laparoscopic Sleeve Gastrectomy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • sufficient understanding
  • good observance of medical prescription
  • availability of a responsible adult for the first operative night
  • patients living nearby the hospital (1 h maximum away)
  • telephonic accessibility
  • between 18 and 60 years old adults
  • body mass index less than 60 kg/m2
  • obesity requiring bariatric surgery
  • surgery validated by an obesity-related staff

You may not qualify if:

  • patient under administrative or legal protection
  • obesity without HAS criteria
  • cardiovascular comorbidity
  • pulmonary comorbidity
  • curative anticoagulant therapy
  • bad diabetes control
  • body mass index higher than 60 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Universitary 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

  • Badaoui R, Alami Chentoufi Y, Hchikat A, Rebibo L, Popov I, Dhahri A, Antoun G, Regimbeau JM, Lorne E, Dupont H. Outpatient laparoscopic sleeve gastrectomy: first 100 cases. J Clin Anesth. 2016 Nov;34:85-90. doi: 10.1016/j.jclinane.2016.03.026. Epub 2016 May 3.

    PMID: 27687352RESULT

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

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 16, 2012

First Posted

January 20, 2012

Study Start

May 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2013

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations

FR(1)