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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorProuse Giorgio

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

125 Participants
are divided into 1 treatment group

Sponsors and collaborators

Prouse Giorgio

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona

Sponsor institution