NCT Number: NCT07580443
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Luzerner Kantonspital, Lucerne, Switzerland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 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.
Time frame: 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
Contact information is provided by the study sponsor or research team.
Elena Garbero, Msc.
CONTACT
Giorgio Prouse, MD
CONTACT
Prouse Giorgio
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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