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Not Yet RecruitingNCT07431047

Fast-Track Protocol for Endovascular Aneurysm Repair (EVAR) of Infrarenal Abdominal Aortic Aneurysms

Fast-Track Protocol for Infrarenal EVAR

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
50 (estimated)
Sponsor
University of Bologna · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The study aims to evaluate the clinical and economic efficacy of a "Fast-Track" protocol for the elective endovascular treatment (EVAR) of infrarenal abdominal aortic aneurysms (AAA). The protocol minimizes invasiveness through the use of local/locoregional anesthesia, a total percutaneous approach, and the avoidance of routine Intensive Care Unit (ICU) admission. The primary goal is to reduce hospital Length of Stay (LOS) to \<48 hours and decrease procedural costs, while maintaining safety and increasing patient turnover compared to the standard of care.

Detailed description

Endovascular Aneurysm Repair (EVAR) is the guideline-recommended treatment for AAA. Despite its minimally invasive nature, standard pathways often involve general anesthesia (80% of historical cases at the institution) and ICU monitoring. The Vascular Surgery Unit at Policlinico Sant'Orsola proposes a structured Fast-Track protocol involving: 1. Strict Patient Selection: Based on anatomical suitability ("Green/Yellow" criteria) and social support availability. 2. Peri-operative Management: Same-day admission, procedure performed in a Hybrid Operating Room under local/locoregional anesthesia with percutaneous access. Minimization of invasive monitoring (no central venous catheter, no urinary catheter). 3. Post-operative Care: Early mobilization, oral intake on Day 0, and planned discharge on Post-Operative Day (POD) 1 or 2. 4. Follow-up: Telemedicine assessment on POD 3, outpatient visit on POD 6, and CT Angiography at 30 days. The study compares outcomes against historical data (Year 2025) to assess reductions in ICU usage, complications, and costs.

Conditions

Timeline

Start date
2026-02-11
Primary completion
2026-12-31
Completion
2027-12-31
First posted
2026-02-24
Last updated
2026-02-24

Source: ClinicalTrials.gov record NCT07431047. Inclusion in this directory is not an endorsement.