Complex Abdominal Aortic Aneurysms
Conditions
Keywords
Complex abdominal aortic aneurysms, SF-36, Quality of Life, Open surgical repair
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.
Interventions
OTHERTo assess changes in health-related quality of life (HRQoL) using the Short Form-36 (SF-36) questionnaire
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
Sponsors
Prouse Giorgio
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in health-related Quality of Life | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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 |
Countries
Switzerland
Contacts
CONTACTGiorgio Prouse, MD
CONTACTElena Garbero, Msc.
Outcome results
None listed