Fast-Track Protocol for Infrarenal EVAR
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Technical Success
研究概览
简要总结
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.
详细描述
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:
- Strict Patient Selection: Based on anatomical suitability ("Green/Yellow" criteria) and social support availability.
- 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).
- Post-operative Care: Early mobilization, oral intake on Day 0, and planned discharge on Post-Operative Day (POD) 1 or 2.
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Patient diagnosed with infrarenal Abdominal Aortic Aneurysm (AAA) indicated for elective endovascular repair.
- •Patient diagnosed with Penetrating Aortic Ulcer (PAU) indicated for elective endovascular repair.
- •Patient resident in the Bologna metropolitan area OR able to remain within the area for at least 7 days post-procedure.
- •Patient with a cohabitant or caregiver available (cannot live alone) to ensure safety during the early post-discharge phase.
- •Signed informed consent specifically for local/locoregional anesthesia, the procedure and the specific fast-track pathway.
- •Common femoral arteries diameter > 7 mm
- •Common femoral arteries free of severe calcification (< 50% of vessel circumference), suitable for percutaneous closure device
- •Proximal aortic neck length > 15 mm
- •Proximal aortic neck diameter < 30 mm
- •Proximal aortic neck without severe angulation (<60°) or circumferential thrombus <50%
排除标准
- •Patient resident outside the Bologna metropolitan area or unable to remain within the area for at least 7 days post-procedure.
- •Patient without a cohabitant or caregiver available
- •Common femoral arteries diameter <7 mm
- •Common femoral arteries with severe calcification (> 50% of vessel circumference), unsuitable for percutaneous closure device
- •Proximal aortic neck length < 15 mm
- •Proximal aortic neck diameter > 30 mm
- •Proximal aortic neck with severe angulation (>60°) or circumferential thrombus >50%
- •General anesthesia
- •Open conversion
- •Medical contraindication to local/locoregional anesthesia or patient refusal/inability to cooperate during the procedure.
- •Severe Chronic Kidney Disease (glomerular filtration rate > 30 ml/min) requiring exclusively CO2 angiography
- •Ruptured or symptomatic aneurysms requiring emergency repair.
- •Clinical condition requiring intensive invasive monitoring (e.g., CVC, urinary catheter) prior to the procedure.
研究组 & 干预措施
Fast-Track EVAR Cohort
Patients with infrarenal Abdominal Aortic Aneurysm (AAA) undergoing elective Endovascular Aneurysm Repair (EVAR) under local or locoregional anesthesia, managed with the multidisciplinary Fast-Track protocol (percutaneous access, early mobilization, and planned discharge within 24-48 hours).
结局指标
主要结局
Technical Success
时间窗: Intra-operative
Technical success is defined as a single composite endpoint. A participant is considered to have achieved technical success only if all of the following criteria are met: successful deployment of the endograft with exclusion of the aneurysm, absence of type I/III endoleaks, patent access vessels, and no conversion to open surgery.. Unit of Measure: Percentage of participants
30-Day Aorta-Related Mortality
时间窗: 30 days
This outcome is reported as a single overall percentage. Aorta-related mortality is defined as death resulting from any of the following causes: directly attributable to the aortic pathology (e.g., rupture, progression of disease) OR complications related to the procedure/device. A participant experiencing death from any of these specific causes is counted only once towards this single aggregate percentage. Unit of Measure: Percentage of participants
次要结局
- Mean Length of Stay (LOS)(From hospital admission to discharge, assessed up to 30 days. Unit of Measure: Days)
- ICU Admission Rate(Time Frame: Intra-operative up to Post-Operative Day 1)
- 30-Day Mortality and Morbidity(30 days)
- Patient Turnover Rate(1 year)
研究者
Enrico Gallitto
Associate Professor
University of Bologna