- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01774682
Kinematics of Obese Patients Perambulation (MARCHOBESE)
September 16, 2025 updated by: Centre Hospitalier Universitaire, Amiens
Does the Sleeve Gastrectomy Improve the Kinematics of Obese Patients Perambulation ?
The aim of this study is to evaluate the consequences of sleeve gastrectomy on functional parameters of patients perambulation.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Laparoscopic Sleeve gastrectomy is the standard surgical procedure for the treatment of obese patients.
Even the surgery is well described, there is no available study about its influence on the functional parameters of patients perambulation.
Study Type
Interventional
Enrollment (Actual)
99
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Amiens, France, 80054
- CHU Amiens
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- history of bariatric surgery
- major cardiac insufficiency
- pregnancy or breastfeeding
- no social welfare
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 6-minute walk test
the 6-minute walk test is performed for each patient prior to the surgery and 6 months after by a specialist.
|
the test corresponds to that defined by Abdel Kafi et al in 2005
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6-minute walk test
Time Frame: 6 months after the surgery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
quality of life
Time Frame: 6 months after the surgery
|
the quality of life is evaluated by the SF36 questionnaire which is performed before the surgery and 6 months after.
|
6 months after the surgery
|
|
BAROS score
Time Frame: 6 months after the surgery
|
the baros score is evaluated by the surgeon during the consultation 6 months after the surgery
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6 months after the surgery
|
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quality of life with the Mooreheald-Ardelt questionnaire
Time Frame: 6 months after the surgery
|
the Mooreheald-Ardelt questionnaire is completed by the patient during the consultation 6 months after the surgery
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6 months after the surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: abdennaceur dhahri, MD, CHU Amiens
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
January 22, 2013
First Submitted That Met QC Criteria
January 22, 2013
First Posted (Estimated)
January 24, 2013
Study Record Updates
Last Update Posted (Estimated)
September 19, 2025
Last Update Submitted That Met QC Criteria
September 16, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI11-PR-VERHAEGHE
- 2012-A00153-40 (Other Identifier: ANSM)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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