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临床试验/NCT01583790
NCT01583790Unknown不适用

A Prospective Trial for Laparoscopic Adjustable Gastric Banding in Morbidly Obese Patients: Report on Weight Loss, Metabolic Changes and Quality of Life

Assuta Hospital Systems1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,000
试验地点
1
主要终点
Weightloss of patients

研究概览

简要总结

The purpose of this study is to report data with patients after bariatric surgery.

详细描述

In the period 2006-2012 the ICBS-Israeli Center for Bariatric Surgery in Assuta Hospital has performed about 1500 bariatric surgeries including Laparoscopic Adjustable Gastric Banding, Laparoscopic Sleeve Gastrectomy, Laparoscopic Roux en Y Gastric Bypass, and Duodenal switch. In addition, Pose and BPD procedures were performed.The ICBS team is comprised of a team of expert senior professionals in the obesity field, made up of the best bariatric surgeons, an expert endocrinologist who specializes in obesity and diabetes, a team of senior nutritionists and a supportive psychology team. During that period patients data were collected as part of the medical practice in the Center and included BMI, co-morbidities, weight loss programs the patients were involved in, pervious bariatric surgery and quality of life. During the entire 6 years of follow up data were collected which included weight loss, resolution of co-morbidity, changes in quality of life etc combined with training for healthy lifestyle.

The purpose of this retrospective study is to evaluate the key factors for surgery success that includes over 50% of original weight loss, resolution of co-morbidities. Factors that could affect surgical outcome such as age, repeated surgery, early side effects such as bleeding, leakage, thrombosis and lung emboli were recorded as well as later side effects such as herniation of the surgical area, production of gallbladder stones, vitamine deficiency and requirement of a revision surgery.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
14 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients meeting established criteria set by the National Institutes of Health (NIH) for candidacy for bariatric surgery
  • patients having a body mass index (BMI) of 35 with co-morbid conditions or BMI larger or equal 40 with or without co-morbid conditions,
  • patients having a comorbidity that should be improved by the surgery
  • Patients that are able to comprehend the risks and benefits and the surgical procedure
  • patients having no glandular etiology for their obesity
  • patients that have attempted to lose weight by conventional means
  • patients that are willing to be observed over a long period of time

排除标准

  • patients that can not obey one of the inclusion criteria

结局指标

主要结局

Weightloss of patients

时间窗: At least one year

次要结局

  • Improvement of co-morbidities after surgery(At least one year)

研究者

发起方
Assuta Hospital Systems
申办方类型
Other
责任方
Sponsor

研究点 (1)

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