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

Not Applicable

Recruiting

• Conditions: Bariatric Surgery Candidate; Obesity, Morbid
• Interventions: Procedure: Bariatric surgery

• Registration Number: NCT02310178
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study Start: 2012-05-21
• Study First Submitted: 2014-10-28
• Study First Submitted QC: 2014-12-03
• Study First Posted: 2014-12-08
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-02
• Last Update Posted: 2024-05-03
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 750

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group/Cohort	Bariatric surgery	all of the current bariatric surgeries are allowed in this prospective cohort study

Primary Outcome Measures

Name	Time	Method
Assessment of the long-term efficiency of bariatric surgery on weight loss	Change from intervention to 5 years	Assessment of weight loss

Secondary Outcome Measures

Name	Time	Method
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 rheumatism	Change from intervention to 5 years	Assessment of rheumatism medications
Assessment of the long-term efficiency of bariatric surgery on sleep apnea syndrome	Change from intervention to 3 months	polysomnography tests
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
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 quality of life	Change from intervention to 5 years	Assessment of quality of life questionnaires (SF36 and BAROS)
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

Trial Locations

Locations (1)

CHRU - Hôpital Saint Eloi; 🇫🇷 Montpellier, France