Patient-Reported Quality of Life After Open Surgery for Complex Abdominal Aortic Aneurysms: A Prospective Study
Prouse Giorgio
125 participants
Mar 18, 2026
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- Patients over 18 years old
- Patients undergoing open surgical repair for complex abdominal aortic aneurysms (AAAs), including juxtarenal, pararenal and suprarenal/paravisceral aneurysms
- Patients treated for asymptomatic or symptomatic non ruptured aneurysms
- Patients who are able and willing to provide informed, complete, and accurate responses to the SF-36 questionnaire
Exclusion Criteria4
- 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 other conditions that prevent them from reliably completing the SF-36 questionnaires.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Patients enrolled in the study will perform the Short Form-36 Health Survey (SF-36) to assess quality of life at five different time points
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07580443