Patient-Reported Quality of Life After Open Surgery for Complex Abdominal Aortic Aneurysms: A Prospective Study

Recruiting now

Conditions studied: Complex Abdominal Aortic Aneurysms

In brief

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.

Key facts

Study ID: NCT07580443
Run by: Prouse Giorgio
People needed: 125
Starts: 2026-03-18
Expected to finish: 2027-12-31
Last updated by the study team: 2026-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

EOC - Ospedale Regionale di Lugano, Civico — Lugano, Switzerland (enrolling)
Luzerner Kantonspital — Lucerne, Switzerland

Full record on ClinicalTrials.gov

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