Effect of Preoperative Simulator Warmup on Intraoperative Robotic Surgical Skills
2020年11月9日 更新者:Johns Hopkins University
Effect of Preoperative Warmup on a Simulator by Trainee Surgeons on Intraoperative Robotic Surgical Skill and Postoperative Patient Outcomes
Surgical residents and fellows acquire operative knowledge and skills by assisting attending surgeons in the operating room.
Previous research has shown that practising technical skills prior to operating on patients can improve how skillfully laparoscopic surgery can be performed.
Although an increasingly large number of patients are undergoing robotic hysterectomy and other robotic surgical procedures, little is known on how to ensure patient safety and treatment effectiveness when trainee surgeons participate in the operating room.
Our study aims to determine the impact of immediate preoperative warm-up on a robotic surgery simulator by gynecologic surgical trainees on their intraoperative performance and on patient outcomes.
The investigators are randomly assigning gynecologic surgical trainees at a major academic medical center to either warm-up immediately before surgery on a robotic surgery simulator or to not warm-up.
The attending surgeon supervising the trainee in the operating room is unaware of whether the trainee was assigned to warm-up or no warm-up.
The investigators will compare standard robotic surgical skills assessments of the trainees by the supervising attending surgeons and patient outcomes in the two groups.
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
22
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Maryland
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Baltimore、Maryland、美国、21205
- Johns Hopkins Hospital
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Baltimore、Maryland、美国、21224
- Johns Hopkins Bayview Medical Center
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Enrollment in the graduate (residency and fellowships) gynecology training program at the study institution;
- Participation as assistant surgeon in a robotic hysterectomy for benign indications for early stage uterine or cervical cancer.
Exclusion Criteria:
- Participation as assistant surgeon in a non-robotic hysterectomy or robotic hysterectomy for gynecologic cancer that has spread beyond the uterus based on preoperative imaging and biopsy.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Preoperative warm-up on simulator
Trainees perform standard practice tasks programmed into a robotic surgical simulator immediately before the surgery.
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无干预:No preoperative warm-up
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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 |
|---|---|---|
|
Global rating score - GEARS approach
大体时间:Assessed during the surgery (scheduled immediately following warm-up/no warm-up)
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Global rating scores assigned by the supervising surgeon immediately after each study surgical procedure.
Global rating scores use two different approaches - the Objective Structured Assessment of Surgical Skills (OSATS) and the Global Evaluative Assessment of Robotic Surgery (GEARS).
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Assessed during the surgery (scheduled immediately following warm-up/no warm-up)
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Global rating score - OSATS approach
大体时间:Assessed during the surgery (scheduled immediately following warm-up/no warm-up)
|
Global rating scores assigned by the supervising surgeon immediately after each study surgical procedure.
Global rating scores use two different approaches - the Objective Structured Assessment of Surgical Skills and the Global Evaluative Assessment of Robotic Surgery.
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Assessed during the surgery (scheduled immediately following warm-up/no warm-up)
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Surgical skill metrics
大体时间:Assessed during the surgery (scheduled immediately following warm-up/no warm-up)
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Computed using surgical tool motion and/or video of procedure.
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Assessed during the surgery (scheduled immediately following warm-up/no warm-up)
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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手术时间
大体时间:术中
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术中
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估计失血量
大体时间:术中
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术中
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Length of hospital stay
大体时间:We will follow patients in the study for the duration of their hospital stay; an anticipated average of about 5 days.
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We will follow patients in the study for the duration of their hospital stay; an anticipated average of about 5 days.
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Change in hematocrit
大体时间:Postoperative days 1, 2, and 3
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Postoperative days 1, 2, and 3
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Readmission or emergency room visit
大体时间:6 weeks after discharge from hospital (following initial admission for surgery)
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6 weeks after discharge from hospital (following initial admission for surgery)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Grace CC Chen, M.D.、Johns Hopkins University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年12月1日
初级完成 (实际的)
2014年6月1日
研究完成 (实际的)
2014年6月1日
研究注册日期
首次提交
2013年9月25日
首先提交符合 QC 标准的
2013年10月24日
首次发布 (估计)
2013年10月25日
研究记录更新
最后更新发布 (实际的)
2020年11月12日
上次提交的符合 QC 标准的更新
2020年11月9日
最后验证
2020年11月1日
更多信息
与本研究相关的术语
其他研究编号
- NA_00074621
- WU_00074621 (其他标识符:Other)
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.