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

Bariatric Surgery Candidate Clinical Trial

— BAREVAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02310178
• Other study ID #: UF 8855
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2012
• Est. completion date: May 2026

Study information

• Verified date: May 2024
• Source: University Hospital, Montpellier
• Contact: David NOCCA, PUPH
• Phone: 0467337731
• Email: d-nocca[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity
• Obesity, Morbid

Intervention

Procedure:
• Bariatric surgery
all of the current bariatric surgeries are allowed in this prospective cohort study

Locations

Country	Name	City	State
France	CHRU - Hôpital Saint Eloi	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the long-term efficiency of bariatric surgery on weight loss	Assessment of weight loss	Change from intervention to 5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	Assessment of the long-term efficiency of bariatric surgery on rheumatism	Assessment of rheumatism medications	Change from intervention to 5 years
Secondary	Assessment of the long-term efficiency of bariatric surgery on respiratory pathologies	Assessment of respiratory pathologies medications	Change from intervention to 5 years
Secondary	Assessment of the long-term efficiency of bariatric surgery on sleep apnea syndrome	polysomnography tests	Change from intervention to 3 months
Secondary	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
Secondary	Assessment of medico-economic impact of bariatric surgery	Comparison of health insurance data	Change from intervention to 5 years
Secondary	Assessment of mortality of bariatric surgery	Assessment of the date of death	Change from intervention to 5 years