Morbid ObesityPhase 3MARCHOBESENCT01774682
Kinematics of Obese Patients Perambulation
A Phase 3 study testing 6-minute walk test in people with Morbid Obesity and Surgical Management by Laparoscopic Sleeve Gastrectomy, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The aim of this study is to evaluate the consequences of sleeve gastrectomy on functional parameters of patients perambulation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity, Surgical Management by Laparoscopic Sleeve Gastrectomy
- What is being tested?
- 6-minute walk test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Jan 2014
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- history of bariatric surgery
- major cardiac insufficiency
- pregnancy or breastfeeding
- no social welfare
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- 6-minute walk test
- Keywords
- obesity, surgery
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-minute walk testProcedure or surgery
the test corresponds to that defined by Abdel Kafi et al in 2005
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: 6-minute walk test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months after the surgery
Secondary outcomes (3)
quality of life
the quality of life is evaluated by the SF36 questionnaire which is performed before the surgery and 6 months after.
Measured: 6 months after the surgery
BAROS score
the baros score is evaluated by the surgeon during the consultation 6 months after the surgery
Measured: 6 months after the surgery
quality of life with the Mooreheald-Ardelt questionnaire
the Mooreheald-Ardelt questionnaire is completed by the patient during the consultation 6 months after the surgery
Measured: 6 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- abdennaceur dhahri, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774682
- Sponsor's protocol ID
- PI11-PR-VERHAEGHE
- Other IDs
- 2012-A00153-40
- Acronym
- MARCHOBESE
- Status last verified
- Sep 2025
- First submitted
- 22 Jan 2013
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23001573Rebibo 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.
PubMed 22884227Pequignot 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.
PubMed 22809752Rebibo 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.
PubMed 22790710Dhahri 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 20971049Rebibo 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.
PubMed 27387694
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Sleeve Gastrectomy Improve the Kinematics of Obese Patients Perambulation ?
- ClinicalTrials.gov ID
- NCT01774682
- Acronym / sponsor ID
- MARCHOBESE / PI11-PR-VERHAEGHE
- Keywords
- obesity, surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 24 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the consequences of sleeve gastrectomy on functional parameters of patients perambulation.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 6-minute walk test | Other | Procedure: 6-minute walk testthe 6-minute walk test is performed for each patient prior to the surgery and 6 months after by a specialist. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- history of bariatric surgery
- major cardiac insufficiency
- pregnancy or breastfeeding
- no social welfare
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6-minute walk testthe test corresponds to that defined by Abdel Kafi et al in 2005 | Procedure or surgery | 6-minute walk test |
Primary outcome
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
3 secondary outcomes
quality of life
Time frame: 6 months after the surgery
BAROS score
Time frame: 6 months after the surgery
quality of life with the Mooreheald-Ardelt questionnaire
Time frame: 6 months after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Background: PubMed 23001573Rebibo 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.
- Background: PubMed 22884227Rebibo 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.
- Background: PubMed 22809752Pequignot 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.
- Background: PubMed 22790710Rebibo 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.
- Background: PubMed 20971049Dhahri 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.
- Results publication: PubMed 27387694Rebibo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
abdennaceur dhahri, MD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 6-minute walk test in people with Morbid Obesity and Surgical Management by Laparoscopic Sleeve Gastrectomy, 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 4 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
6-minute walk test (time frame: 6 months 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 NCT01774682, 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; AzTrials last refreshed its copy on 6 Nov 2026.