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临床试验/NCT04216433
NCT04216433已完成不适用

A Large Surgical Registry for Abdominal Aortic Aneurysms (AAA)

Methodist Health System1 个研究点 分布在 1 个国家目标入组 394 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
394
试验地点
1
主要终点
Overall survival

研究概览

简要总结

In the spirit of improving patient safety and quality of healthcare in our region, the Dallas-Fort Worth Hospital Council Education and Research Foundation (Foundation) and Baylor Research Institute sought and obtained federal funding support (AHRQ grant) to develop an Abdominal Aortic Aneurism (AAA) surgery registry in North Texas. Participating centers will directly benefit from this project and will have access to a de-identified version of the registry data through their collaboration. These data may be used for quality improvement initiatives and/or to conduct your own research. In summary, this effort represents a substantial investment (with no costs to facilities) in improving outcomes for patients with AAA.

详细描述

Currently, little is known about who receives which type of surgery. What data are available are largely from single-centre studies, with study populations of a few hundred to a thousand patients, comparing outcomes for open and endovascular repair and collecting patient characteristic data largely for risk adjustment. Data on endovascular vs open AAA repair from the population-based registry will provide important information regarding the current use of these two treatment strategies, as well as allowing comparison of long-term outcomes for each according to different patient characteristics.

The proposed registry has the potential to provide means for internal quality assessment for the participating institutions. The de-identified registry will be made available to researchers at their request. This registry, focusing on AAA in the Dallas-Fort Worth metroplex, will provide data with the potential to improve treatments for more than 800,000 patients in the US.

研究设计

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

入排标准

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

入选标准

  • Men and women who received endovascular or open AAA repair (primary/secondary procedure codes: ICD-9=38.44 for open, ICD-9=39.71 for endovascular repair) at any of the 138 Dallas-Fort Worth area hospitals that report AAA data to the DFWHC Data Initiative.
  • patients age 50 years old or older.

排除标准

  • Patients with HIV and substance abuse
  • Patients with substance abuse
  • Patients > 50 years old

结局指标

主要结局

Overall survival

时间窗: 2000 to 2009

time (in days) from first AAA surgery to death (any cause)

Time to re-operation

时间窗: 2000 to 2009

time (in days) from first AAA surgery to AAA re-operation

Time to rupture

时间窗: 2000 to 2009

time (in days) from first AAA surgery to AAA rupture

次要结局

  • Type of AAA surgery(day of surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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