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Clinical Trials/NCT02310178
NCT02310178
Recruiting
Not Applicable

Obesity Cohort : Medical Follow-up of Severe or Morbid Obese Patients Undergoing Bariatric Surgery

University Hospital, Montpellier1 site in 1 country750 target enrollmentMay 21, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity, Morbid
Sponsor
University Hospital, Montpellier
Enrollment
750
Locations
1
Primary Endpoint
Assessment of the long-term efficiency of bariatric surgery on weight loss
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The aim of this cohort is to evaluate the follow-up of morbidly obese patients treated by several types of bariatric procedures. In addition, this study could lead to the development of clinical trials on assessment of the bariatric surgery impact.

Detailed Description

The main objective is to prospectively evaluate long-term efficiency of bariatric surgery in terms of weight loss. Moreover, this cohort wants to assess the long-term effectiveness of bariatric surgery on comorbidities and quality of life, the medical and economic impact of bariatric surgery (before-after comparison using data from health insurance), estimates the incidence of mortality and morbidity of bariatric surgery and to finish describe the evolution of patients in case of new-surgery. From a methodological point of view, the Obesity cohort is a prospective cohort study, single-center, open, with aftercare performed during life of patients. The number of inclusions is to 1500 patients. After surgery , patients will be followed at least 4 visits the first year and at least 2 visits a year then. The recommendations of the french health ministry (HAS), the frequency of visits may be increased according to the patient's progress. Follow-up visits of patients after bariatric surgery will be performed by physicians or surgeons of the multidisciplinary team responsible for the care of the patient (digestive and reconstructive surgery, anesthesiology, endocrinology, medical imaging, gastroenterology, immunology and physiology) . It will be insured for life, obesity is a chronic disease and because of the risk of late complications.

Registry
clinicaltrials.gov
Start Date
May 21, 2012
End Date
May 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Only be considered in patients operated and followed at CHU Montpellier with bariatric surgery
  • Patients treated by bariatric surgery on CHU Montpellier
  • Agreed to participate to the study by signing an informed consent
  • Eligible to health insurance

Exclusion Criteria

  • Unable to follow the patient in the long term (foreign patients, surgical use ...)
  • Inability to follow in the long run

Outcomes

Primary Outcomes

Assessment of the long-term efficiency of bariatric surgery on weight loss

Time Frame: Change from intervention to 5 years

Assessment of weight loss

Secondary Outcomes

  • Assessment of the long-term efficiency of bariatric surgery on diabetes(Change from intervention to 5 years)
  • Assessment of the long-term efficiency of bariatric surgery on High Blood Pressure(Change from intervention to 5 years)
  • Assessment of the long-term efficiency of bariatric surgery on rheumatism(Change from intervention to 5 years)
  • Assessment of the long-term efficiency of bariatric surgery on sleep apnea syndrome(Change from intervention to 3 months)
  • Assessment of medico-economic impact of bariatric surgery(Change from intervention to 5 years)
  • Assessment of mortality of bariatric surgery(Change from intervention to 5 years)
  • Assessment of the long-term efficiency of bariatric surgery on respiratory pathologies(Change from intervention to 5 years)
  • Assessment of the long-term efficiency of bariatric surgery on quality of life(Change from intervention to 5 years)
  • Assessment of the long-term efficiency of bariatric surgery on dyslipidemia(Change from intervention to 5 years)

Study Sites (1)

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