QoL After Complex Endovascular Aortic Repair
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Early physical component score changes after standard or complex EVAR procedure.
研究概览
简要总结
The goal of this prospective observational cohort study is to compare health related quality of life in patients with abdominal aortic aneurysms treated by either standard or complex EVAR (endovascular aneurysm repair) devices. The main questions it aims to answer are:
- Compare differences between the physical scores from the preoperative to the postoperative settings between patients treated with standard EVAR vs non-standard endovascular aortic repair (F-/BEVAR)
- To compare long-term physical scores postoperatively between patients treated with standard EVAR vs non-standard endovascular aortic repair (F-/BEVAR) at one year.
- To explore at which time points (if ever) patients treated with standard-EVAR and nonstandard endovascular aortic repair (F-/BEVAR) have restored or normalized physical scores measured by SF-12, measured at 30 days, 6 months, 1 and 3 years.
Participants will be asked to fill out forms pre- and postoperatively with regards to health related quality of life.
The different groups for comparison will be either standard EVAR for infrarenal aortic aneurysms or complex EVAR (fenestrated or branched) for paravisceral aortic aneurysms (PVAAA).
详细描述
Prospective cohort study with patients planned for elective aortic endovascular repair during a two year time period. The estimated recruitment period is February 2023 - February 2025.
All patients with infrarenal or paravisceral aortic aneurysms planned for treatment with EVAR or F-/BEVAR will be invited to participate in the study at the time of consent of the proposed treatment.
The questionnaires to be filled out will be available online or by paper form. Patient- and aneurysm related variables will be recorded at the time of treatment decision. The endpoint is 3 years of follow up or death. Analysis will be done by both intention-to-treat and per protocol.
The questionnaires to be used are:
- SF-12
- EQ5D
- HADS
- Custom made questionnaire: Education, marital status and need for domestic service
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
- •Men and women.
- •Any age (≥18 years)
- •Planned (elective) endovascular treatment by EVAR, FEVAR or BEVAR.
- •Patients previously treated by EVAR which are planned for an adjunct fenestrated cuff will not be included in the basic analysis, but included and analysed separately.
排除标准
- •Inability to understand and/or respond to the study questionnaires that are in Swedish.
- •Inability to provide an informed consent for participation in the study, orally or in writing (This may be due to linguistic or cognitive limitation).
- •Participation in other ongoing studies concerning quality of life.
结局指标
主要结局
Early physical component score changes after standard or complex EVAR procedure.
时间窗: 2026
To compare the difference between the physical scores from the preoperative to the postoperative settings between patients treated with standard EVAR vs non-standard endovascular aortic repair (F-/BEVAR) at 30 days.
次要结局
- Late physical component score changes after standard or complex EVAR procedure.(2026)
- When does physical component scores return to normal after standard or complex EVAR procedures?(2028)
研究者
Rebecka Hultgren
Adjunct professor
Karolinska University Hospital