Actively Recruiting
Patient-Reported Quality of Life After Open Surgery for Complex Abdominal Aortic Aneurysms: A Prospective Study
Led by Prouse Giorgio · Updated on 2026-05-12
125
Participants Needed
2
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
STUDY DURATION: January 2026 - December 2027 Each participant will be followed for 12 months postoperatively. BACKGROUND AND RATIONALE: Complex abdominal aortic aneurysms (cAAAs)-including juxtarenal, pararenal, and suprarenal aneurysms-can be treated via open surgical repair (OSR) or complex endovascular techniques (f/bEVAR). While OSR may offer better long-term durability, especially in fit patients, there is currently a lack of data on patient-reported quality of life (QoL) outcomes following OSR for cAAAs. This study aims to fill this gap and support shared decision-making in vascular surgery. OBJECTIVES: * Primary Objective: To assess changes in health-related quality of life (HRQoL) using the Short Form-36 (SF-36) questionnaire at five predefined time points (baseline, discharge, 1 month, 6 months, and 12 months post-surgery). * Secondary Objectives: To analyze QoL differences by patient subgroups (e.g., age, comorbidities, aneurysm type), to assess correlations with clinical outcomes (e.g., complications, hospital stay), and to evaluate the impact of postoperative complications on QoL. STUDY POPULATION: * Inclusion criteria: Adults (≥18 years) undergoing OSR for non-ruptured complex AAAs (juxtarenal, pararenal, suprarenal). * Exclusion criteria: Patients under 18, those with ruptured AAAs, cognitive impairment, or those unable to complete the SF-36 questionnaire. PARTICIPATING CENTERS: * Ospedale Regionale di Lugano (EOC), Switzerland * Luzerner Kantonsspital, Switzerland * Centre Hospitalier Universitaire de Montpellier, France STUDY PROCEDURES: * Administration of the SF-36 questionnaire at five time points: preoperative, at discharge (within 7 days), and at 1, 6, and 12 months postoperatively. * Data collection includes demographic information, aneurysm characteristics, in-hospital and follow-up outcomes, and questionnaire responses.
CONDITIONS
Official Title
Patient-Reported Quality of Life After Open Surgery for Complex Abdominal Aortic Aneurysms: A Prospective Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years old
- Patients undergoing open surgical repair for complex abdominal aortic aneurysms, including juxtarenal, pararenal, and suprarenal/paravisceral aneurysms
- Patients treated for asymptomatic or symptomatic non-ruptured aneurysms
- Patients able and willing to provide complete and accurate responses to the SF-36 questionnaire
You will not qualify if you...
- Patients under 18 years old
- Patients treated for ruptured abdominal aortic aneurysms
- Patients with incomplete data or who denied consent
- Patients with cognitive impairment or conditions preventing reliable completion of the SF-36 questionnaire
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Luzerner Kantonspital
Lucerne, Switzerland, 6004
Not Yet Recruiting
2
EOC - Ospedale Regionale di Lugano, Civico
Lugano, Switzerland, 6900
Actively Recruiting
Research Team
G
Giorgio Prouse, MD
CONTACT
E
Elena Garbero, Msc.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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