A Large Surgical Registry for Abdominal Aortic Aneurysms (AAA)

Completed

• Conditions: Abdominal Aortic Aneurism

• Registration Number: NCT04216433
• Lead Sponsor: Methodist Health System

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-12-30
• Study First Posted: 2020-01-02
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01
• Status Verified: 2024-09
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 394

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	2000 to 2009	time (in days) from first AAA surgery to death (any cause)
Time to re-operation	2000 to 2009	time (in days) from first AAA surgery to AAA re-operation
Time to rupture	2000 to 2009	time (in days) from first AAA surgery to AAA rupture

Secondary Outcome Measures

Name	Time	Method
Type of AAA surgery	day of surgery	either open or endovascular AAA surgery

Trial Locations

Locations (1)

Methodist Health System; 🇺🇸 Dallas, Texas, United States