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

Prouse Giorgio125 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

125

Conditions

Complex Abdominal Aortic Aneurysms

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in health-related Quality of Life

The primary end point will be the analysis of change in health-related Quality of Life as measured by the SF-36 score between 5 time points.

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 Outcomes

QoL trajectory differences between subgroups

Secondary outcomes will include quality of life (QoL) trajectory differences between subgroups (e.g., age groups, comorbidity burden, aneurysm complexity), correlation between QoL outcomes and clinical variables (e.g., length of hospital stay, Intensive Care Unit (ICU) duration, postoperative complications), and incidence of postoperative complications and their impact on QoL