Evaluation of Effort and Time Efficiency of Surgical Theater's Surgery Rehearsal Platform (SRP) for Cerebral Aneurysm Clipping Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Aneurysm Clip Time
研究概览
简要总结
Objectives: The objective of this clinical study is to determine if the use of the SRP will lead to improved effort and time efficiency in cerebral aneurysm surgery. For this preliminary study, the investigators will assess key time and effort variables associated with prospectively assessed SRP neurosurgery cases in comparison with cases with no SRP rehearsal. This is a single site study with one enrolling site. This study will include a total of 40 cases 20 SRP cases and 20 control cases). SRP and control cases will be randomly selected according to a predetermined alternating sequence.
详细描述
Overview: This study is a blinded, multicenter, randomized study comparing key effort and time variables in 20 prospective SRP cases to these same effort and time variables in 20 video recorded control neurosurgery cases. SRP and control cases will be randomly selected according to a predetermined alternating sequence.
Effort will be assessed as the number of clipping attempts and clip evaluations, as identified by a blinded, trained rater observing video recorded SRP neurosurgical cases and control neurosurgery cases. Time will be assessed as the time that the vessel was temporarily occluded as well as total microsurgical time.
To maximize the potential effects of the SRP platform on learning, cases in the protocol will be limited to those in which the Chief Neurosurgery Resident or Cerebrovascular Fellow performs a majority of the microsurgical dissection. Their participation in this study will be that of a researcher, not of a participant.
The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches. Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period. Inclusion/exclusion criteria for SRP cases and control cases will define clinically similar patient groups. Only patients who, in the opinion of their physicians, qualify for the clipping procedure will be considered for this study. The purpose of this project is to determine if simulated practice for the surgeon prior to surgery using the SRP will lead to better effort and time efficiency. Findings will be used to inform development of a larger and more rigorous trial of the SRP if the preliminary results are promising. Inclusion/exclusion criteria are as follows:
Inclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient age >=18 years old with unruptured or ruptured cerebral aneurysm in the anterior circulation for which craniotomy and microsurgery is recommended
- •Patients scheduled to undergo surgery for clipping of a cerebral aneurysm, per a.
- •Able to provide written informed consent
排除标准
- •Repeat of aneurysm surgery
- •Previous history of craniotomy for any reason
- •Previous history of non-aneurysmal hemorrhagic stroke
- •Pregnancy
- •Posterior circulation
- •Giant (25 mm or larger) aneurysm
- •Nonsaccular aneurysm
结局指标
主要结局
Aneurysm Clip Time
时间窗: At time of surgery-Time (minutes/seconds) from first clip attempt to final clip position(up to 5 minutes)
Number of Clipping attempts: 1. Applying a clip (i.e., closing a clip on the aneurysm) 2. Removing a clip (i.e., a clip was applied on the aneurysm and then removed) 3. Adjusting a clip (i.e., the clip was applied on the aneurysm and then opened, adjusted, and closed again).
次要结局
- Number of Trial Aneurysm Clips Used But Not Implanted(At time of surgery-Time (minutes/seconds) from first clip to contact aneurysm to final clip placement)
研究者
Nicholas Bambakidis
Director, Cerebrovascular and Skull Based Surgery
University Hospitals Cleveland Medical Center