Patient-specific Virtual Reality Rehearsal Prior to EVAR: Influence on Technical and Non-technical Operative Performance. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Errors occurring during EVAR procedure (Imperial College Error Capture record)
研究概览
简要总结
Ongoing technological advances, especially in the field of image processing, have refined medical simulations to offer life-like replications of medical and surgical procedures in a variety of specialties. Patient-specific image data are incorporated into these simulations, and transformed into a 3D model. This enables the practitioner and his/her team to perform and practice 'real' cases on a virtual patient prior to performing the real procedure on the actual patient. This new technology has been referred to as 'patient-specific' rehearsal, also 'mission' or 'procedure' rehearsal.
Research has already proven that simulated patient-specific rehearsal of a carotid artery stenting procedure may enhance surgical and team performance.
The PROcedure rehearsal software can now also be used to practice patient-specific endovascular repair of infrarenal aortic aneurysms (EVAR). The ability to rehearse a challenging and complex procedure like EVAR may not only influence device selection based on preoperative planning, but also improve the technical performance of the surgeon/radiologist and the awareness and communication within the entire endovascular team. However, further research is needed to evaluate if this new technology may enhance clinical safety and efficiency, i.e. if patients actually benefit from physicians and team members conducting patient-specific rehearsals of EVAR interventions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •infrarenal aortic aneurysm suitable for endovascular exclusion
排除标准
- •Adult patients who do not have capacity to consent.
- •Previous stent-graft implanted in the abdominal aorta
结局指标
主要结局
Errors occurring during EVAR procedure (Imperial College Error Capture record)
时间窗: during EVAR procedure
Technical operative metrics
时间窗: during EVAR procedure
* C-arm positioning for proximal and distal landing zone * Fluoroscopy time * Number of angiograms * Amount of contrast
次要结局
- 30 day mortality and morbidity(within the first 30 days after surgery)
- Subjective sense of realism of patient-specific rehearsal reported by team members(immediately after EVAR procedure)
- Team satisfaction(immediately after EVAR procedure)
- Any deviation from initial treatment plan(immediately after EVAR procedure)
- Technical and clinical success rate(immediately after EVAR procedure)
- Initial clinical success(within the first 30 days after surgery)
