Actively Recruiting
Quality of Life After Standard or Complex Endovascular Aortic Repair of Abdominal Aortic Aneurysms
Led by Karolinska University Hospital · Updated on 2025-04-10
90
Participants Needed
1
Research Sites
161 weeks
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women
- Age 18 years or older
- Planned elective endovascular treatment by EVAR, fenestrated EVAR (FEVAR), or branched EVAR (BEVAR)
- Patients previously treated by EVAR planned for adjunct fenestrated cuff will be included but analyzed separately
You will not qualify if you...
- Inability to understand or respond to study questionnaires in Swedish
- Unable to provide informed consent due to language or cognitive limitations
- Participation in other ongoing quality of life studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) at the time of treatment decision
Duration - Elective procedure period
Participants undergo standard or complex endovascular aortic repair for abdominal aortic aneurysms.
1 procedure visit (in-person)
Duration - 3 years
Participants complete quality of life questionnaires before and after the procedure to monitor physical and mental health outcomes.
Questionnaires completed preoperatively (<90 days before surgery), and at 30 days, 6 months, 12 months, and 36 months postoperatively
Trial Site Locations
Total: 1 location
1
Karolinska University Hospital
Stockholm, Sweden, 17176
Actively Recruiting
Research Team
R
Rebecka Hultgren, MD, PhD
M
Mårten Huss, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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