跳至主要内容
临床试验/NCT01632631
NCT01632631已完成不适用

Patient-specific Virtual Reality Rehearsal Prior to EVAR: Influence on Technical and Non-technical Operative Performance. A Randomized Controlled Trial.

University Hospital, Ghent3 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2012年9月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

Loading locations...

相似试验