Validation Study for Robotic Surgery Simulator
研究概览
详细说明
Objective: To determine whether a group of surgeons otherwise naive to robotic techniques could demonstrate proficiency during their first robotic supracervical hysterectomy having only received simulator and pig lab training.
Primary outcome measure: As measured by time spent on the surgeon console from beginning of hysterectomy until the end of cervical amputation.
Secondary Outcome measures:
- Blood loss- as measured by the blood suctioned into the canister throughout the hysterectomy and at the end of the amputation discounting irrigation volume.
- Surgical skill rating- All procedures will be recorded and rated by a blinded investigator according to a standardized surgical skills evaluation sheet.
- Surgeon console biometrics- As measured by controller movements and grips
- Novice robotic surgeon data: Descriptive Operative data of surgeons who did not participate in robotic simulator training.
Methods: To create the simulator protocol, 5 robotic surgeons (each averaging >75 robotic cases per year) performed all 28 simulation modules available on the da Vinci Skills Simulator. To establish "expert benchmarks", they picked the 10 simulator modules they thought were most beneficial to robotic novices', and they performed each of these 10 modules to the best of their ability >5 times. The data was used to create benchmarks in which all parameters of these 10 modules were taken into account (i.e. not just the time to completion). Thus the "Morristown Protocol" was established- whereby successful completion of the protocol required passing every parameter of all 10 simulator modules at the expert level.
We then recruited community board-certified OB-GYN's who were completely naive to robotics and offered them full robotic training free-of-charge as long as they could pass the "Morristown Protocol" as their very first step in the training process. These "study surgeons" were given 24/7 access to the da Vinci Skills Simulator and simply asked to complete the protocol at their own pace. Within a week of doing so, they went through the standardized Intuitive Surgical pig lab and then performed their first ever robotic surgery- a supracervical hysterectomy- as our main outcome measure. These cases were performed using the dual-console daVinci system with one of the senior authors on the other console ready to step in if necessary.
Two sets of comparative benchmarks for this surgical procedure has been established. Our "expert surgeons" each performed supracervical hysterectomies for the study- as did a group of "control surgeons". These "control surgeons" had full robotic privileges but were not averaging more than 2 cases per month and had never used the simulator. Operative time, EBL, and a blinded skill assessment (of videos) were compared for all cases among the 3 surgeon groups using t-tests.
研究类型
注册 (实际的)
联系人和位置
学习地点
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New Jersey
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Morristown、New Jersey、美国、07960
- Morristown Medical Center
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Must not have performed a da Vinci assisted surgery
Exclusion Criteria:
- prior experience on the da Vinci system or the robotic simulator
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Expert Surgeons
Gynecologic robotic surgeons, each averaging >75 robotic cases per year
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All groups were recorded, times and graded on their performance during a robotic supracervical hysterectomy
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Study Surgeons
Gynecologic surgeons who are completely naive to robotics
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All groups were recorded, times and graded on their performance during a robotic supracervical hysterectomy
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Control Surgeons
Gynecologic surgeons with full robotic privileges but were not averaging more than 2 cases a month and had never used the simulator
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All groups were recorded, times and graded on their performance during a robotic supracervical hysterectomy
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Surgical Time
大体时间:At end of cervical amputation
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As measured by time spent on the surgeon console from beginning of hysterectomy until the end of cervical amputation
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At end of cervical amputation
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Blood Loss
大体时间:End of cervical amputation
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As measured by the blood suctioned into the canister throughout the hysterectomy and at the end of the amputation discounting irrigation volume
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End of cervical amputation
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Surgical Skill Rating
大体时间:Within a month of the performed surgery
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All procedures will be recorded and rated by a blinded investigator according to a standardized surgical skills evaluation sheet
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Within a month of the performed surgery
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Surgeon Console Biometrics
大体时间:during surgery
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As measured by controller movements and grip
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during surgery
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Novice Robotic Surgeon Data
大体时间:Within a month of the performed surgery
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Descriptive Operative data of surgeons who did not participate in robotic simulator training
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Within a month of the performed surgery
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合作者和调查者
调查人员
- 首席研究员:Charbel Salamon, MD、Atlantic Health System
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
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