A Large Surgical Registry for Abdominal Aortic Aneurysms (AAA)

Abdominal Aortic Aneurism Clinical Trial

— AAA  

Official title:

A Large Surgical Registry for Abdominal Aortic Aneurysms (AAA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04216433
• Other study ID #: 2012.00.591.A
• Status: Completed
• Start date: January 2012
• Est. completion date: July 1, 2021

Study information

• Verified date: December 2021
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 394
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurism
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Procedure:
• endovascular surgery
an innovative, less invasive procedure used to treat problems affecting the blood vessels, such as an aneurysm, which is a swelling or "ballooning" of the blood vessel. The surgery involves making a small incision near each hip to access the blood vessels.

Locations

Country	Name	City	State
United States	Methodist Health System	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	time (in days) from first AAA surgery to death (any cause)	2000 to 2009
Primary	Time to re-operation	time (in days) from first AAA surgery to AAA re-operation	2000 to 2009
Primary	Time to rupture	time (in days) from first AAA surgery to AAA rupture	2000 to 2009
Secondary	Type of AAA surgery	either open or endovascular AAA surgery	day of surgery