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

NCT07580443 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 125

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

  • Complex Abdominal Aortic Aneurysms

Interventions

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

Sponsors & Collaborators

  • Prouse Giorgio

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-18
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07580443 on ClinicalTrials.gov