Patient-Reported Quality of Life After Open Surgery for Complex Abdominal Aortic Aneurysms: A Prospective Study
Key facts
- Who runs it
- Prouse Giorgio
- Where
- Lucerne and Lugano, SwitzerlandSee the 2 sites
- Trial code
- Status
- Recruiting
- People taking part
- 125 people, planned
- Started
- 18 Mar 2026
- Expected to end
- 31 Dec 2027
- Type of study
- Observational
- Treatments tested
- To assess changes in health-related quality of life (HRQoL) using the Short Form-36 (SF-36) questionnaire
- Record updated
- 28 September 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- Patients with cognitive impairment or other conditions that prevent them from reliably completing the SF-36 questionnaires
- Patients under 18 years old
- Patients treated for ruptured abdominal aortic aneurysms
- Patients with incomplete data, or who denied consent
Where in Switzerland
- Luzerner KantonspitalLucerne, SwitzerlandContact: Maani Hakimi, Prof.Not yet recruiting
- EOC - Ospedale Regionale di Lugano, CivicoLugano, SwitzerlandContact: Elena Garbero, MSc.Taking people
About the trial
What the trial wants to find out
STUDY DURATION: January 2026 - December 2027 Each participant will be followed for 12 months postoperatively.
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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.
The group in the trial
- Patients undergoing open surgical repair for complex abdominal aortic aneuysms
Treatment: To assess changes in health-related quality of life (HRQoL) using the Short Form-36 (SF-36) questionnaire
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 28 September 2026