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

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ClinicalTrials.gov Identifier: NCT02310178
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : December 8, 2014
Last Update Posted : December 8, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obesity, Morbid Bariatric Surgery Candidate Procedure: Bariatric surgery Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Obesity Cohort : Medical Follow-up of Severe or Morbid Obese Patients Undergoing Bariatric Surgery
Study Start Date : May 2012
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Group/Cohort
all of the current bariatric surgeries are allowed in this prospective cohort study
Procedure: Bariatric surgery
all of the current bariatric surgeries are allowed in this prospective cohort study




Primary Outcome Measures :
  1. Assessment of the long-term efficiency of bariatric surgery on weight loss [ Time Frame: Change from intervention to 5 years ]
    Assessment of weight loss


Secondary Outcome Measures :
  1. Assessment of the long-term efficiency of bariatric surgery on diabetes [ Time Frame: Change from intervention to 5 years ]
    Assessment of blood glucose, HbA1c and diabetes medications

  2. Assessment of the long-term efficiency of bariatric surgery on High Blood Pressure [ Time Frame: Change from intervention to 5 years ]
    Assessment of Systolic Blood Pressure and blood pressure medications

  3. Assessment of the long-term efficiency of bariatric surgery on dyslipidemia [ Time Frame: Change from intervention to 5 years ]
    Assessment of cholesterolemia and triglyceridemia and dyslipidemia medications

  4. Assessment of the long-term efficiency of bariatric surgery on rheumatism [ Time Frame: Change from intervention to 5 years ]
    Assessment of rheumatism medications

  5. Assessment of the long-term efficiency of bariatric surgery on respiratory pathologies [ Time Frame: Change from intervention to 5 years ]
    Assessment of respiratory pathologies medications

  6. Assessment of the long-term efficiency of bariatric surgery on sleep apnea syndrome [ Time Frame: Change from intervention to 3 months ]
    polysomnography tests

  7. Assessment of the long-term efficiency of bariatric surgery on quality of life [ Time Frame: Change from intervention to 5 years ]
    Assessment of quality of life questionnaires (SF36 and BAROS)

  8. Assessment of medico-economic impact of bariatric surgery [ Time Frame: Change from intervention to 5 years ]
    Comparison of health insurance data

  9. Assessment of mortality of bariatric surgery [ Time Frame: Change from intervention to 5 years ]
    Assessment of the date of death



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310178


Contacts
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Contact: David NOCCA, PUPH 0467337731 ext +33 d-nocca@chu-montpellier.fr

Locations
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France
CHRU - Hôpital Saint Eloi Recruiting
Montpellier, France, 34295
Contact: David NOCCA, PUPH    0467337731 ext +33    d-nocca@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02310178     History of Changes
Other Study ID Numbers: UF8855
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014

Keywords provided by University Hospital, Montpellier:
weight loss
sleeve gastrectomy
gastric bypass
gastric banding
bariatric procedures
cohort
morbid obesity
medical and economical impact
severe obesity

Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms