Clinical trial NCT02310178: Obesity Cohort : Medical Follow-up of Severe or Morbid Obese Patients Undergoing Bariatric Surgery
Official title: Obesity Cohort : Medical Follow-up of Severe or Morbid Obese Patients Undergoing Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Morbid
Bariatric Surgery Candidate
Keywords: weight loss
sleeve gastrectomy
gastric bypass
gastric banding
bariatric procedures
cohort
morbid obesity
medical and economical impact
severe obesity
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 750
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Assessment of the long-term efficiency of bariatric surgery on weight loss
timeFrame: Change from intervention to 5 years
Secondary outcomes:
measure: Assessment of the long-term efficiency of bariatric surgery on diabetes
timeFrame: Change from intervention to 5 years
measure: Assessment of the long-term efficiency of bariatric surgery on High Blood Pressure
timeFrame: Change from intervention to 5 years
measure: Assessment of the long-term efficiency of bariatric surgery on dyslipidemia
timeFrame: Change from intervention to 5 years
measure: Assessment of the long-term efficiency of bariatric surgery on rheumatism
timeFrame: Change from intervention to 5 years
measure: Assessment of the long-term efficiency of bariatric surgery on respiratory pathologies
timeFrame: Change from intervention to 5 years
measure: Assessment of the long-term efficiency of bariatric surgery on sleep apnea syndrome
timeFrame: Change from intervention to 3 months
measure: Assessment of the long-term efficiency of bariatric surgery on quality of life
timeFrame: Change from intervention to 5 years
measure: Assessment of medico-economic impact of bariatric surgery
timeFrame: Change from intervention to 5 years
measure: Assessment of mortality of bariatric surgery
timeFrame: Change from intervention to 5 years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHRU - Hôpital Saint Eloi
Study officials:
References:
citation: Nocca D, Galtier F, Taleb S, Picot MC, Jaussent A, Silvestri M, Lefebvre P, de Jong A, Gautier T, Loureiro M, Nedelcu M. Peri-operative Morbidity of Nissen Sleeve Gastrectomy: Prospective Evaluation of a Cohort of 365 Patients, Beyond the Learning Curve. Obes Surg. 2022 Jul;32(7):1-7. doi: 10.1007/s11695-022-06066-0. Epub 2022 May 7.