Impact of a Patient-specific Simulation on the Learning Curve of Infra-renal Aneurysm Endovascular Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Fluoroscopy time
研究概览
简要总结
The purpose of this study is to produce a patient-specific simulator for endovascular infra-renal aneurysm repair training and than analyze the effect of simulator training on the performance of vascular surgery residents.
详细描述
Title: Production of a patient-specific simulator for endovascular aneurysm repair training.
Clinics Hospital of São Paulo University Medical School
Introduction
The aorta aneurysm is a common clinical condition that implies in considerable threatening to the life of patients. Before the year 2000, 99% of the abdominal aortic aneurysm (AAA) repair where performed with open surgery. Nevertheless, Catheter-based minimally invasive interventions are rapidly becoming the preferred initial treatment in patients with vascular disease . After 2004, the endovascular treatment of AAA increased to 52%. This changing venue requires a shift in our approach to training both fellows as well as general surgical residents during their exposure to vascular surgery.
Currently, supervised training with progressive exposure to procedures is the norm. Nevertheless, simulations based training may allow a shortening of the learning curve and avoid the exposure of the patients to unnecessary risks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with infra-renal aneurysm with diameter of 5,5cm or more
- •Residents of the last year of vascular surgery at Clinics Hospital of São Paulo University Medical School
排除标准
- •Patients not suitable for endovascular aneurysm repair
- •Patients with iliac aneurysm that require iliac bifurcated grafts
- •Residents who don't want participate
研究组 & 干预措施
Group 1
30 patients/5 vascular surgery residents The residents of the last year of vascular surgery will perform the procedure under supervision of a senior surgeon
Group 2
30 patients/5 vascular surgery residents Patients will have their aneurysm impressed by a 3D printing. The senior vascular surgeon and the residents of this group will be able to practice the procedure in the model as many times as they wish before the surgery. After the training, the EVAR will be performed according to the routine of the hospital.
干预措施: Training (Procedure)
结局指标
主要结局
Fluoroscopy time
时间窗: 2 years - all the surgeries
The total fluoroscopy time in every surgery will be counted, measured in minutes
次要结局
- Death(30 days)
- Contrast volume in each surgery(2 years)
- Number of participants with Myocardial infarction.(30 days)
- Technical success (Endoprosthesis located in the right position, no endoleak type 1)(30 days)
- Number of participants with Renal disfunction(30 days)
- Number of participants with Pulmonary complications(30 days)