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

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 Overview

• Status: Recruiting
• Conditions: Complex Abdominal Aortic Aneurysms
• Intervention / Treatment: Other: To assess changes in health-related quality of life (HRQoL) using the Short Form-36 (SF-36) questionnaire

• Study Type: Observational
• Enrollment (Estimated): 125

Contacts and Locations

• Study Contact: Name: Giorgio Prouse, MD; Phone Number: +410918116328; Email: giorgio.prouse@eoc.ch
• Study Contact Backup: Name: Elena Garbero, Msc.; Email: elena.garbero@eoc.ch

Study Locations

• Switzerland
  • Lucerne, Switzerland, 6004
    • Not yet recruiting
    • Luzerner Kantonspital
    • Contact: Maani Hakimi, Prof.; Phone Number: +41 041 205 48 88; Email: maani.hakimi@luks.ch
    • Principal Investigator: Maani Hakimi, Prof.
  • Lugano, Switzerland, 6900
    • Recruiting
    • EOC - Ospedale Regionale di Lugano, Civico
    • Contact: Elena Garbero, MSc.; Phone Number: +41 091 811 63 28; Email: elena.garbero@eoc.ch
    • Principal Investigator: Giorgio Prouse, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing open surgical repair for complex abdominal aortic aneuysms	Other: To 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
QoL trajectory differences between subgroups	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	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.

Collaborators and Investigators

• Sponsor: Prouse Giorgio

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; SF-36; Open surgical repair; Complex abdominal aortic aneurysms
• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Health Status; Demography; Epidemiologic Measurements; Surveys and Questionnaires; Quality of Life
• Other Study ID Numbers: 2025-01639

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No