跳至主要内容
临床试验/NCT02310178
NCT02310178招募中不适用

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

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2012年5月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
750
试验地点
2
主要终点
Assessment of the long-term efficiency of bariatric surgery on weight loss

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Unable to follow the patient in the long term (foreign patients, surgical use ...)
  • Inability to follow in the long run

研究组 & 干预措施

Group/Cohort

Other

all of the current bariatric surgeries are allowed in this prospective cohort study

干预措施: Bariatric surgery (Procedure)

结局指标

主要结局

Assessment of the long-term efficiency of bariatric surgery on weight loss

时间窗: Change from intervention to 5 years

Assessment of weight loss

次要结局

  • Assessment of the long-term efficiency of bariatric surgery on diabetes(Change from intervention to 5 years)
  • Assessment of the long-term efficiency of bariatric surgery on High Blood Pressure(Change from intervention to 5 years)
  • Assessment of the long-term efficiency of bariatric surgery on rheumatism(Change from intervention to 5 years)
  • Assessment of the long-term efficiency of bariatric surgery on sleep apnea syndrome(Change from intervention to 3 months)
  • Assessment of medico-economic impact of bariatric surgery(Change from intervention to 5 years)
  • Assessment of mortality of bariatric surgery(Change from intervention to 5 years)
  • Assessment of the long-term efficiency of bariatric surgery on respiratory pathologies(Change from intervention to 5 years)
  • Assessment of the long-term efficiency of bariatric surgery on quality of life(Change from intervention to 5 years)
  • Assessment of the long-term efficiency of bariatric surgery on dyslipidemia(Change from intervention to 5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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