Patient-Reported Quality of Life After Open Surgery for Complex Abdominal Aortic Aneurysms: A Prospective Study
- Complex Abdominal Aortic Aneurysms
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Prouse Giorgio
- Enrolment target
- 125
- Started
- 18 March 2026
- Main results due
- 31 December 2027
- Study sites
- 2
- Registry updated
- 28 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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.
What this study is about
In the sponsor’s own words, from the registry.
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 sites(2)
Luzerner Kantonspital
Lucerne, Switzerland
Not yet recruiting
EOC - Ospedale Regionale di Lugano, Civico
Lugano, Switzerland
Recruiting
Showing 2 of 2 sites. 1 of the 2 sites on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07580443. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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