Kinematics of Obese Patients Perambulation (MARCHOBESE)

This study is not yet open for participant recruitment.

Verified December 2012 by Centre Hospitalier Universitaire, Amiens

Sponsor:

Information provided by (Responsible Party):

Centre Hospitalier Universitaire, Amiens

ClinicalTrials.gov Identifier:

NCT01774682

First received: January 22, 2013

Last updated: NA

Last verified: December 2012

History: No changes posted

Purpose

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

Condition	Intervention	Phase
Morbid Obesity Surgical Management by Laparoscopic Sleeve Gastrectomy	Procedure: 6-minute walk test	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Does the Sleeve Gastrectomy Improve the Kinematics of Obese Patients Perambulation ?

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire, Amiens:

Primary Outcome Measures:

6-minute walk test [ Time Frame: 6 months after the surgery ] [ Designated as safety issue: No ]
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

Secondary Outcome Measures:

quality of life [ Time Frame: 6 months after the surgery ] [ Designated as safety issue: No ]
the quality of life is evaluated by the SF36 questionnaire which is performed before the surgery and 6 months after.
BAROS score [ Time Frame: 6 months after the surgery ] [ Designated as safety issue: No ]
the baros score is evaluated by the surgeon during the consultation 6 months after the surgery
quality of life with the Mooreheald-Ardelt questionnaire [ Time Frame: 6 months after the surgery ] [ Designated as safety issue: No ]
the Mooreheald-Ardelt questionnaire is completed by the patient during the consultation 6 months after the surgery

Estimated Enrollment:	100
Study Start Date:	January 2013
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Procedure: 6-minute walk test the test corresponds to that defined by Abdel Kafi et al in 2005

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774682

Contacts

Contact: pierre verhaeghe, MD, FACS

+33 3 22 66 83 03

verhaeghe.pierre@chu-amiens.fr

Locations

France
Chu Amiens	Not yet recruiting
Amiens, France, 80054
Contact: PIERRE VERHAEGHE, MD, FACS +33 3 22 66 83 03 verhaeghe.pierre@chu-amiens.fr
Sub-Investigator: abdennaceur dhahri, MD

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Investigators

Principal Investigator:

abdennaceur dhahri, MD

CHU Amiens

More Information

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.

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.

Péquignot 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.

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. No abstract available.

Responsible Party:	Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:	NCT01774682 History of Changes
Other Study ID Numbers:	PI11-Pr. VERHAEGHE, 2012-A00153-40
Study First Received:	January 22, 2013
Last Updated:	January 22, 2013
Health Authority:	France: National Consultative Ethics Committee for Health and Life Sciences France: The Commission nationale de l’informatique et des libertés

Keywords provided by Centre Hospitalier Universitaire, Amiens:

obesity
surgery

Additional relevant MeSH terms:

Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013

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