Patient-Reported Quality of Life After Open Surgery for Complex Abdominal Aortic Aneurysms: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Change in health-related Quality of Life
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Patients undergoing open surgical repair for complex abdominal aortic aneuysms
干预措施: To assess changes in health-related quality of life (HRQoL) using the Short Form-36 (SF-36) questionnaire (Other)
结局指标
主要结局
Change in health-related Quality of Life
时间窗: 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.
次要结局
- 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.)
研究者
Prouse Giorgio
MD
Ente Ospedaliero Cantonale, Bellinzona