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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:
STUDY POPULATION:
PARTICIPATING CENTERS:
STUDY PROCEDURES:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing open surgical repair for complex abdominal aortic aneuysms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| To assess changes in health-related quality of life (HRQoL) using the Short Form-36 (SF-36) questionnaire | Other | 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 |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giorgio Prouse, MD | Contact | +410918116328 | giorgio.prouse@eoc.ch | |
| Elena Garbero, Msc. | Contact | elena.garbero@eoc.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luzerner Kantonspital | Not yet recruiting | Lucerne | 6004 | Switzerland |
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| 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. |
| EOC - Ospedale Regionale di Lugano, Civico | Recruiting | Lugano | 6900 | Switzerland |
|
| ID | Term |
|---|---|
| D011788 | Quality of Life |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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