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Factors Influencing the Positive Outcome of Bariatric Surgery for Morbidly Obese Patients

2018年1月24日 更新者:Assuta Hospital Systems

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

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

研究概览

地位

未知

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

观察性的

注册 (预期的)

2000

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Tel Aviv、以色列
        • 招聘中
        • Assuta Medical Center
        • 接触:
        • 首席研究员:
          • Asnat Raziel, MD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

14年 至 65年 (孩子、成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The study includes about 1500 patients, 70% female and 30% male. All patients that had bariatric surgery and were in the follow-up group for longer than one month will take part in the study. A special emphasis will be given to special population groups such as adolescents, old patients, patients undergoing revision surgery, and patients that required a additional type of surgery in conjunction with the bariatric surgery (e.g., gallbladder removal).

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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

在这里您可以找到参与这项研究的人员和组织。

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

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年1月1日

初级完成 (预期的)

2019年1月1日

研究完成 (预期的)

2020年1月1日

研究注册日期

首次提交

2012年4月23日

首先提交符合 QC 标准的

2012年4月23日

首次发布 (估计)

2012年4月24日

研究记录更新

最后更新发布 (实际的)

2018年1月25日

上次提交的符合 QC 标准的更新

2018年1月24日

最后验证

2017年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • AR-001-12

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.

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