Kinematics of Obese Patients Perambulation

Morbid Obesity Clinical Trial

— MARCHOBESE  

Official title:

Does the Sleeve Gastrectomy Improve the Kinematics of Obese Patients Perambulation ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01774682
• Other study ID #: PI11-PR-VERHAEGHE
• Secondary ID: 2012-A00153-40
• Status: Completed
• Phase: Phase 3
• First received: January 22, 2013
• Last updated: April 25, 2016
• Start date: January 2013
• Est. completion date: January 2014

Study information

• Verified date: April 2016
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Consultative Ethics Committee for Health and Life SciencesFrance: The Commission nationale de l’informatique et des libertés
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid
• Surgical Management by Laparoscopic Sleeve Gastrectomy

Intervention

Procedure:
• 6-minute walk test
the test corresponds to that defined by Abdel Kafi et al in 2005

Locations

Country	Name	City	State
France	Chu Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	quality of life	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	No
Secondary	BAROS score	the baros score is evaluated by the surgeon during the consultation 6 months after the surgery	6 months after the surgery	No
Secondary	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	6 months after the surgery	No