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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Morbid, Bariatric Surgery Candidate

Intervention / Treatment
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* Procedure: Bariatric surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group/Cohort<br>all of the current bariatric surgeries are allowed in this prospective cohort study | Procedure: Bariatric surgery<br>* all of the current bariatric surgeries are allowed in this prospective cohort study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the long-term efficiency of bariatric surgery on weight loss | Assessment of weight loss | Change from intervention to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the long-term efficiency of bariatric surgery on diabetes | Assessment of blood glucose, HbA1c and diabetes medications | Change from intervention to 5 years | 
| Assessment of the long-term efficiency of bariatric surgery on High Blood Pressure | Assessment of Systolic Blood Pressure and blood pressure medications | Change from intervention to 5 years | 
| Assessment of the long-term efficiency of bariatric surgery on dyslipidemia | Assessment of cholesterolemia and triglyceridemia and dyslipidemia medications | Change from intervention to 5 years | 
| Assessment of the long-term efficiency of bariatric surgery on rheumatism | Assessment of rheumatism medications | Change from intervention to 5 years | 
| Assessment of the long-term efficiency of bariatric surgery on respiratory pathologies | Assessment of respiratory pathologies medications | Change from intervention to 5 years | 
| Assessment of the long-term efficiency of bariatric surgery on sleep apnea syndrome | polysomnography tests | Change from intervention to 3 months | 
| Assessment of the long-term efficiency of bariatric surgery on quality of life | Assessment of quality of life questionnaires (SF36 and BAROS) | Change from intervention to 5 years | 
| Assessment of medico-economic impact of bariatric surgery | Comparison of health insurance data | Change from intervention to 5 years | 
| Assessment of mortality of bariatric surgery | Assessment of the date of death | Change from intervention to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight loss, sleeve gastrectomy, gastric bypass, gastric banding, bariatric procedures, cohort, morbid obesity, medical and economical impact, severe obesity