CHRU - Hôpital Saint Eloi
Montpellier, 34295, France
Location status: Recruiting
NCT Number: NCT02310178
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.
Interested in participating?
Request Info15 year and older
All sexes
Interventional
Not applicable
Montpellier, 34295, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
all of the current bariatric surgeries are allowed in this prospective cohort study
Time frame: Change from intervention to 5 years
Assessment of weight loss
Time frame: Change from intervention to 5 years
Assessment of blood glucose, HbA1c and diabetes medications
Time frame: Change from intervention to 5 years
Assessment of Systolic Blood Pressure and blood pressure medications
Time frame: Change from intervention to 5 years
Assessment of cholesterolemia and triglyceridemia and dyslipidemia medications
Time frame: Change from intervention to 5 years
Assessment of rheumatism medications
Time frame: Change from intervention to 5 years
Assessment of respiratory pathologies medications
Time frame: Change from intervention to 3 months
polysomnography tests
Time frame: Change from intervention to 5 years
Assessment of quality of life questionnaires (SF36 and BAROS)
Time frame: Change from intervention to 5 years
Comparison of health insurance data
Time frame: Change from intervention to 5 years
Assessment of the date of death
Contact information is provided by the study sponsor or research team.
University Hospital, Montpellier
Other
Acronym: BAREVAL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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