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临床试验/NCT05777447
NCT05777447招募中不适用

Long Term Results of Aorto-iliac Mycotic Aneurysms

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Early mortality

研究概览

简要总结

The term mycotic aneurysm (MA) is commonly used to describe all infected aneurysms. Although MAs are believed to occur uncommonly, the true incidence is difficult to determine and is probably underestimated since MAs can be asymptomatic and are diagnosed only at autopsy. In an autoptic study, mycotic aortic aneurysms (MAAs) were reported in 3.3% of all detected aneurysms. The incidence of infected aneurysms of the aorta and iliac arteries ranges from 0.6% to 1.3%.

A recent literature review of the management of MAAs showed that therapeutic strategies are multiple, including open surgical repair (OSR) in the majority of cases, endovascular aortic repair (EVAR), which increased over the last decade, and medical treatment alone for patients unfit for any aortic repair in a very limited part. Following the unfavorable prognosis towards rupture and since the medical treatment alone in mycotic aneurysms has shown mortality of almost 100%, surgical treatment is generally the preferred option.

Surgical treatment includes both open and endovascular surgery. The latter is less invasive than conventional surgery but does not involve resection of the infected tissue and is therefore associated with an increased risk of sepsis and prosthesis infection. The gold standard is still open surgery, including extra-anatomic reconstruction and in situ repair, with different type of vascular graft.

This is a multicenter retrospective observational study. It will examine all patients undergoing surgical treatment of mycotic aortic-iliac aneurysms and in situ reconstruction at the participating centers.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • primary mycotic aorto-iliac aneurysm who underwent in situ repair

排除标准

  • patient with vascular graft infections;
  • patient with secondary aorto-enteric fistula.

结局指标

主要结局

Early mortality

时间窗: Mortality within 30 days after surgery

Mortality after surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

TINELLI GIOVANNI

Prof

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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