Laparoscopic Revision Gastric Bypass for Inadequate Initial Weight Loss (IIWL)
2009年12月28日 更新者:University of California, San Francisco
Laparoscopic Revision Gastric Bypass for Inadequate Initial Weight Loss After Gastric Bypass: Intermediate Results
The main aim of this study is to analyze and report traditional, patient-centered, and composite intermediate-term outcomes after laparoscopic revision Roux-en-Y gastric bypass surgery for inadequate initial weight loss.
研究概览
地位
完全的
详细说明
There is lack of standardization of primary and revisional bariatric surgery compounded by a scant long-term outcome data.
The treatment of inadequate weight loss, weight recidivism, and most severe technical complications after primary bariatric surgery remains refractory to non-operative treatment.
Failure rates have been reported up to 20% and 35% for the morbidly obese (MO) and super obese (SO), respectively at 2 to 3 years after surgery.
The indication for further surgical intervention remains controversial, as does what type of revisional procedure, both operative and endoscopic, to recommend.
Furthermore, there is no standardization of the limb lengths, pouch size or the use of prosthetic reinforcement.
Therefore the approach to these patients must be as individualized as their original operations.
We formally analyze our experience with all laparoscopic revisional strategies for Inadequate Initial Weight Loss after failed Roux-en-Y gastric bypass(RYGB).
研究类型
观察性的
注册 (实际的)
42
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。
学习地点
-
-
California
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Fresno、California、美国、93701
- UCSF Fresno Center for Medical Education and Research
-
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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
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients that underwent laparoscopic revision gastric bypass after previously failed Roux-en-Y gastric bypass "RYGB" with an Inadequate initial weight loss "IIWL" pattern.
描述
Inclusion Criteria:
- laparoscopic revisional RYGB for failed RYGB with IIWL or non-responders pattern
Exclusion Criteria:
- failed RYGB with a WR pattern
- patients with prior major bariatric conversion or esophago-gastric surgeries
- RYGB patients revised by an open surgical approach
- RYGB patients who underwent laparoscopic revisional RYGB surgery somewhere else and continue their follow-up care with program
- missing records and/or unreachable patients with scan information for analysis
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 |
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Inadequate initial weight loss after gastric bypass
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
发病率和死亡率
大体时间:在整个随访过程中
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在整个随访过程中
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与健康相关的生活质量 (HR-QoL)
大体时间:最后跟进
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最后跟进
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合并症状况
大体时间:在整个随访过程中
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在整个随访过程中
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Subjective satisfaction
大体时间:at the last follow-up
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at the last follow-up
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Weight loss expressed as Body Mass Index and Percentage excess weight loss
大体时间:at the lowest weight loss point and at last follow-up
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at the lowest weight loss point and at last follow-up
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Failure/success rate
大体时间:at yearly intervals throughout follow-up
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at yearly intervals throughout follow-up
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Metabolic and nutritional variables
大体时间:throughout follow-up
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throughout follow-up
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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:Kelvin D Higa, MD、Professor of Surgery, University of California San Francisco
- 研究主任:Francisco M Tercero, MD、Research Associate, University of California San Franisco
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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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
2009年10月1日
初级完成 (实际的)
2009年12月1日
研究完成 (实际的)
2009年12月1日
研究注册日期
首次提交
2009年12月23日
首先提交符合 QC 标准的
2009年12月28日
首次发布 (估计)
2009年12月29日
研究记录更新
最后更新发布 (估计)
2009年12月29日
上次提交的符合 QC 标准的更新
2009年12月28日
最后验证
2009年10月1日
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.