NCT01774682

Brief Summary

The aim of this study is to evaluate the consequences of sleeve gastrectomy on functional parameters of patients perambulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_3

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

January 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

January 22, 2013

Last Update Submit

September 16, 2025

Conditions

Morbid ObesitySurgical Management by Laparoscopic Sleeve Gastrectomy

Keywords

obesitysurgery

Outcome Measures

Primary Outcomes (1)

  • 6-minute walk test

    the value of this test is obtained by the difference between the 6-minute walk test performed before the surgery and the 6-minute walk test performed 6 months after the surgery

    6 months after the surgery

Secondary Outcomes (3)

  • quality of life

    6 months after the surgery

  • BAROS score

    6 months after the surgery

  • quality of life with the Mooreheald-Ardelt questionnaire

    6 months after the surgery

Study Arms (1)

6-minute walk test

OTHER

the 6-minute walk test is performed for each patient prior to the surgery and 6 months after by a specialist.

Procedure: 6-minute walk test

Interventions

6-minute walk testPROCEDURE

the test corresponds to that defined by Abdel Kafi et al in 2005

6-minute walk test

Eligibility Criteria

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

You may qualify if:

  • BMI between 40 and 60 kg/m2 or BMI \> 35 kg/m2 with at least one comorbidity
  • no weight loss
  • between 18 and 65 years old
  • history of obesity \> 5 ans

You may not qualify if:

  • history of bariatric surgery
  • major cardiac insufficiency
  • pregnancy or breastfeeding
  • no social welfare

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Amiens

Amiens, 80054, France

Location

Related Publications (6)

  • Rebibo L, Fuks D, Verhaeghe P, Deguines JB, Dhahri A, Regimbeau JM. Repeat sleeve gastrectomy compared with primary sleeve gastrectomy: a single-center, matched case study. Obes Surg. 2012 Dec;22(12):1909-15. doi: 10.1007/s11695-012-0779-9.

    PMID: 23001573BACKGROUND

  • Rebibo L, Dhahri A, Verhaeghe P, Regimbeau JM. Early gastric fistula after laparoscopic sleeve gastrectomy: surgical management. J Visc Surg. 2012 Oct;149(5):e319-24. doi: 10.1016/j.jviscsurg.2012.07.004. Epub 2012 Aug 9. No abstract available.

    PMID: 22884227BACKGROUND

  • Pequignot A, Dhahri A, Verhaeghe P, Desailloud R, Lalau JD, Regimbeau JM. Efficiency of laparoscopic sleeve gastrectomy on metabolic syndrome disorders: two years results. J Visc Surg. 2012 Oct;149(5):e350-5. doi: 10.1016/j.jviscsurg.2012.06.005. Epub 2012 Jul 17.

    PMID: 22809752BACKGROUND

  • Rebibo L, Mensah E, Verhaeghe P, Dhahri A, Cosse C, Diouf M, Regimbeau JM. Simultaneous gastric band removal and sleeve gastrectomy: a comparison with front-line sleeve gastrectomy. Obes Surg. 2012 Sep;22(9):1420-6. doi: 10.1007/s11695-012-0689-x.

    PMID: 22790710BACKGROUND

  • 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

  • Rebibo L, Verhaeghe P, Tasseel-Ponche S, Cosse C, Marechal V, Dhahri A, Doutrellot PL, Regimbeau JM. Does sleeve gastrectomy improve the gait parameters of obese patients? Surg Obes Relat Dis. 2016 Sep-Oct;12(8):1474-1481. doi: 10.1016/j.soard.2016.03.023. Epub 2016 Mar 25.

    PMID: 27387694RESULT

MeSH Terms

Conditions

Obesity, MorbidObesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • abdennaceur dhahri, MD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2013

First Posted

January 24, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations

FR(1)