Kinematics of Obese Patients Perambulation

Phase 3

Completed

• Conditions: Surgical Management by Laparoscopic Sleeve Gastrectomy; Morbid Obesity
• Interventions: Procedure: 6-minute walk test

• Registration Number: NCT01774682
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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 Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-22
• Study First Submitted QC: 2013-01-22
• Study First Posted: 2013-01-24
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-25
• Last Update Posted: 2016-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
6-minute walk test	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.

Primary Outcome Measures

Name	Time	Method
6-minute walk test	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

Secondary Outcome Measures

Name	Time	Method
quality of life	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.
BAROS score	6 months after the surgery	the baros score is evaluated by the surgeon during the consultation 6 months after the surgery
quality of life with the Mooreheald-Ardelt questionnaire	6 months after the surgery	the Mooreheald-Ardelt questionnaire is completed by the patient during the consultation 6 months after the surgery

Trial Locations

Locations (1)

Chu Amiens; 🇫🇷 Amiens, France