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

2026年5月13日 更新者：Prouse Giorgio

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

125

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 瑞士
      • Lucerne、瑞士、6004
        • 尚未招聘
        • Luzerner Kantonspital
        • 接触：
        • 首席研究员：
          • Maani Hakimi, Prof.
      • Lugano、瑞士、6900
        • 招聘中
        • EOC - Ospedale Regionale di Lugano, Civico
        • 接触：
        • 首席研究员：
          • Giorgio Prouse, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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:

  1. Preoperative baseline (prior to surgery)
  2. At hospital discharge (within 7 days after surgery)
  3. 1 month postoperatively
  4. 6 months postoperatively
  5. 12 months postoperatively At each of these time points, participants will complete the Short Form-36 (SF-36) Health Survey questionnaire to assess HRQOL, including physical and mental well-being.

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Patients undergoing open surgical repair for complex abdominal aortic aneuysms
其他：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

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in health-related Quality of Life
大体时间：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.
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.

次要结果测量

结果测量
措施说明
大体时间
QoL trajectory differences between subgroups
大体时间：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
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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Prouse Giorgio

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年3月18日

初级完成 (估计的)

2027年12月31日

研究完成 (估计的)

2027年12月31日

研究注册日期

首次提交

2026年5月5日

首先提交符合 QC 标准的

2026年5月5日

首次发布 (实际的)

2026年5月12日

研究记录更新

最后更新发布 (实际的)

2026年5月15日

上次提交的符合 QC 标准的更新

2026年5月13日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2025-01639

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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