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

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Enrolling

Conditions

Bariatric Surgery Candidate
Obesity, Morbid

Treatments

Procedure: Bariatric surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT02310178
UF 8855

Details and patient eligibility

About

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.

Full 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.

Enrollment

750 estimated patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

750 participants in 1 patient group

Group/Cohort
Other group
Description:
all of the current bariatric surgeries are allowed in this prospective cohort study
Treatment:
Procedure: Bariatric surgery

Trial contacts and locations

1

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Central trial contact

David NOCCA, PUPH

Data sourced from clinicaltrials.gov

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