Actively Recruiting
Quality of Life Study After Standard or Complex Endovascular Aortic Repair For Abdominal and Paravisceral Aortic Aneurysms
Led by Karolinska University Hospital · Updated on 2025-04-10
90
Participants Needed
1
Research Sites
161 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are comparing health-related quality of life in patients with abdominal aortic aneurysms who undergo standard versus complex endovascular aneurysm repair EVAR procedures. This prospective observational cohort study focuses on physical and mental health scores before and after surgery, aiming to identify differences between standard EVAR for infrarenal aneurysms and complex EVAR fenestrated or branched for paravisceral aneurysms. The study will analyze these outcomes over a period of up to three years postoperatively. Participants will receive either standard EVAR using off-the-shelf devices or complex EVAR with custom-made fenestrated or branched devices. These treatments are planned electively, and patients will be grouped according to the type of EVAR they receive. Data collection includes several questionnaires, such as SF-12, EQ5D, HADS, and a custom survey on education, marital status, and domestic service needs. Questionnaires will be completed before surgery and at multiple follow-up points 30 days, 6 months, 12 months, and 36 months after the procedure. During the study, patients will fill out forms online or on paper, reporting on their physical and mental health status. Researchers will record patient and aneurysm characteristics at treatment decision time and follow participants for up to three years or until death. The main outcomes measured are changes in physical and mental health scores at early and late postoperative stages. The study includes monitoring of quality-adjusted life years and comparison of preoperative and postoperative health scores to inform treatment decisions.
CONDITIONS
Brief Title
QoL After Complex Endovascular Aortic Repair
Research Team
R
Rebecka Hultgren, MD, PhD
M
Mårten Huss, MD
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