Bariatric Surgery Candidate, Obesity, Morbid
Conditions
Keywords
weight loss, sleeve gastrectomy, gastric bypass, gastric banding, bariatric procedures, cohort, morbid obesity, medical and economical impact, severe obesity
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.
Interventions
PROCEDUREBariatric surgery
all of the current bariatric surgeries are allowed in this prospective cohort study
Sponsors
University Hospital, Montpellier
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the long-term efficiency of bariatric surgery on weight loss | Change from intervention to 5 years | Assessment of weight loss |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the long-term efficiency of bariatric surgery on diabetes | Change from intervention to 5 years | Assessment of blood glucose, HbA1c and diabetes medications |
| Assessment of the long-term efficiency of bariatric surgery on High Blood Pressure | Change from intervention to 5 years | Assessment of Systolic Blood Pressure and blood pressure medications |
| Assessment of the long-term efficiency of bariatric surgery on dyslipidemia | Change from intervention to 5 years | Assessment of cholesterolemia and triglyceridemia and dyslipidemia medications |
| Assessment of the long-term efficiency of bariatric surgery on rheumatism | Change from intervention to 5 years | Assessment of rheumatism medications |
| Assessment of the long-term efficiency of bariatric surgery on respiratory pathologies | Change from intervention to 5 years | Assessment of respiratory pathologies medications |
| Assessment of the long-term efficiency of bariatric surgery on sleep apnea syndrome | Change from intervention to 3 months | polysomnography tests |
| Assessment of the long-term efficiency of bariatric surgery on quality of life | Change from intervention to 5 years | Assessment of quality of life questionnaires (SF36 and BAROS) |
| Assessment of medico-economic impact of bariatric surgery | Change from intervention to 5 years | Comparison of health insurance data |
| Assessment of mortality of bariatric surgery | Change from intervention to 5 years | Assessment of the date of death |
Countries
France
Contacts
CONTACTDavid NOCCA, PUPH
Outcome results
None listed