Kinematics of Obese Patients Perambulation (MARCHOBESE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 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: November 26, 2013
Last verified: November 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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:
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: November 26, 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 September 30, 2014