International Multicenter Mycotic Aneurysm Aorto-iliac Study

Recruiting

• Conditions: Mycotic Aneurysm; Aortic Diseases

• Registration Number: NCT05777447
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2023-01-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-09
• Study First Submitted QC: 2023-03-09
• Last Update Submitted: 2023-03-09
• Study First Posted: 2023-03-21
• Last Update Posted: 2023-03-21
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Early mortality	Mortality within 30 days after surgery	Mortality after surgery

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Roma, RM, Italy