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

Overview

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.

Interventions

• Other To assess changes in health-related quality of life (HRQoL) using the Short Form-36 (SF-36) questionnaire
  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

Primary outcome measures

• Change in health-related Quality of Life [Time frame: preoperative (baseline), hospital discharge (within 1 week after surgery), 1 month after the procedure, 6 months after the procedure and 1 year after the procedure.]

Secondary outcome measures (1)

• QoL trajectory differences between subgroups [Time frame: preoperative (baseline), hospital discharge (within 1 week after surgery), 1 month after the procedure, 6 months after the procedure and 1 year after the procedure.]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Switzerland · 2 centers

• Luzerner Kantonspital — Lucerne
• EOC - Ospedale Regionale di Lugano, Civico — Lugano

Identifiers

NCT: NCT07580443 · 2025-01639

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗