跳至主要内容
临床试验/NCT03446287
NCT03446287招募中不适用

Clinical Outcomes of Patients Treated With Open Surgical Repair for Complex Aortic Aneurysms

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年7月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
Mayo Clinic
入组人数
150
试验地点
1
主要终点
Change in health-related quality of life after open repair as measured by the Short-Form General Health Survey (SF-36)

研究概览

简要总结

This is a prospective, non-randomized, single center, data collection study of patients treated with open surgical repair (OR) for complex aortic aneurysms (CAAs).

详细描述

Patients in need of OR for CAAs will be placed in this prospective, non-randomized, single center, data collection study. Choice of the prosthetic graft and configuration will be based on surgeon's preference and extent of the disease. OR will be performed by vascular surgeons at Mayo Clinic, Rochester, assuming no difference in surgical techniques.

Demographics, clinical presentation, preoperative clinical and imaging assessment, intraoperative information, length of ICU stay and hospitalization, early and late mortality, major adverse events (MAEs), reintervention, rupture and QoL at different postoperative time points (4 months, 1 year, 3 years and 5 years) will be recorded according to well-designed case report forms (CRFs) and SF-36 form. Follow-up information will be obtained from office visits or mailing questionnaires (SF-36 form and CAA-specific questionnaire).

Patients will be asked to fill out the SF-36 forms preoperatively, and along with the CAA-specific questionnaire at 4 months, 1 year, 3 years and 5 years post-operatively. Physician assistants or study coordinators will interview all patients prior to treatment (during office evaluation). The follow-up assessments will be conducted by questionnaires (SF-36 and CAA-specific questionnaire) and office visits as well. If no response in 6 weeks after sending out questionnaires at each time point, telephone interview will be followed.

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • Patients undergoing elective, emergent or urgent OR for CAAs, including:
  • Abdominal aortic aneurysms (AAA) not eligible for endovascular aneurysm repair (EVAR), including 1) Infrarenal AAA with complex aneurysm morphology 2) Short neck infrarenal AAA 3) Juxtarenal AAA 4) Suprarenal AAA
  • Thoracoabdominal aortic aneurysms (TAAA) (Type I - IV)
  • Chronic aortic dissections

排除标准

  • Patients who refuse to participate the study
  • Patients age < 18 years
  • Pregnant breastfeeding patients

结局指标

主要结局

Change in health-related quality of life after open repair as measured by the Short-Form General Health Survey (SF-36)

时间窗: baseline, 5 years post repair

The SF-36 consists of 8 sub-scales which are additionally summarized into 2 summary components (physical and mental). The subscales and the summary scales both range from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jill J. Colglazier

Principal Investigator

Mayo Clinic

研究点 (1)

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