Clinical trial NCT04216433: A Large Surgical Registry for Abdominal Aortic Aneurysms (AAA)
Official title: A Large Surgical Registry for Abdominal Aortic Aneurysms (AAA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurism
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 394
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: 2000 to 2009
measure: Time to re-operation
timeFrame: 2000 to 2009
measure: Time to rupture
timeFrame: 2000 to 2009
Secondary outcomes:
measure: Type of AAA surgery
timeFrame: day of surgery
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Health System
state: Texas
Study officials:
affiliation: DFW Vascular Group
name: Robert Feldtman, MD
role: PRINCIPAL_INVESTIGATOR
References: