Factors Influencing the Positive Outcome of Bariatric Surgery for Morbidly Obese Patients
A Prospective Trial for Laparoscopic Adjustable Gastric Banding in Morbidly Obese Patients: Report on Weight Loss, Metabolic Changes and Quality of Life
研究概览
详细说明
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.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Asnat Raziel, MD
- 电话号码:972-3-7645444
- 邮箱:drraziel@zahav.net.il
学习地点
-
-
-
Tel Aviv、以色列
- 招聘中
- Assuta Medical Center
-
接触:
- Asnat Raziel, MD
- 电话号码:972-3-7645444
- 邮箱:drraziel@zahav.net.il
-
首席研究员:
- Asnat Raziel, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- patients that can not obey one of the inclusion criteria
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
---|
no group
laparoscopic sleeve gastrectomy
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Weightloss of patients
大体时间:At least one year
|
At least one year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Improvement of co-morbidities after surgery
大体时间:At least one year
|
Follow up visits were done at 1, 3, 6, 9, 12, 24, 36, 48 and 60 months after surgery.
They included physical examinations, blood analysis and assessment of comorbidities in collaboration with attending family physician.
|
At least one year
|
合作者和调查者
调查人员
- 首席研究员:Asnat Raziel, MD、Medical Director, ICBS-Israeli Center for Bariatric Surgery
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.