Patient-Reported Quality of Life After Open Surgery for Complex Abdominal Aortic Aneurysms: A Prospective Study
1 other identifier
observational
125
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 18, 2026
CompletedFirst Submitted
Initial submission to the registry
May 5, 2026
CompletedFirst Posted
Study publicly available on registry
May 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
May 15, 2026
May 1, 2026
1.8 years
May 5, 2026
May 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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 (1)
QoL trajectory differences between subgroups
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.
Study Arms (1)
Patients undergoing open surgical repair for complex abdominal aortic aneuysms
Interventions
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
Eligibility Criteria
Participants will be enrolled by the Department of Vascular Surgery in three different centres. Patients will be included if there is a diagnosis of complex abdominal aortic aneurysms (cAAAs), defined as juxtarenal, pararenal and suprarenal/paravisceral aneurysms. The study includes five time points for data collection: 1. Preoperative baseline (prior to surgery) 2. At hospital discharge (within 7 days after surgery) 3. 1 month postoperatively 4. 6 months postoperatively 5. 12 months postoperatively At each of these time points, participants will complete the Short Form-36 (SF-36) Health Survey questionnaire to assess HRQOL, including physical and mental well-being.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Prouse Giorgiolead
Study Sites (2)
Luzerner Kantonspital
Lucerne, 6004, Switzerland
EOC - Ospedale Regionale di Lugano, Civico
Lugano, 6900, Switzerland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 5, 2026
First Posted
May 12, 2026
Study Start
March 18, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
May 15, 2026
Record last verified: 2026-05