Effect of Simulator Practice on Trainees' Endoscopic Retrograde Cholangiopancreatography (ERCP) Performance in the Early Learning Period
A RCT of Mechanical Simulator Practice and Usual Training vs. Usual Training on Novice Trainee Clinical ERCP Performance
研究概览
详细说明
Background: The impact of mechanical simulator practice on clinical ERCP performance has not been reported.
Hypothesis: Practice with mechanical simulator improves clinical ERCP performance of novice trainees.
Design: A prospective randomized controlled trial.
Method: 8 trainees without prior ERCP experience from 2 hospitals attended didactic lectures on ERCP. They were randomized in pairs (per hospital) to receive simulator practice and usual training (S) versus usual training only as control (C). Simulator practice included selective bile and pancreatic duct cannulation using a catheter and/or guide wire with different artificial papillae (flat, standard, dual channels) and settings (standard, rotated papilla or duodenum), and exchange of guide wire/accessories and biliary stenting. Local trainers tracked trainees' subsequent clinical ERCP performance for 3 months. Evaluation of trainee skills included success of diagnostic CBD and deep CBD cannulation. Trainer blinded to the randomization provided assessment (1=poor, 5=excellent) of each trainee performed ERCP.
Statistics: Fisher exact test and Mann-Whitney U test.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Taipei、台湾
- Department of Gastroenterology, National Taiwan University Hospital
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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
描述
Inclusion Criteria:
- GI trainees who met the minimum endoscopy training experience
Exclusion Criteria:
- GI trainees with no endoscopy experience
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:1
4 half-day of simulator ERCP practice and usual training
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4 half-day of simulator ERCP practice as endoscopist and/or assistant followed by usual training
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有源比较器:2
Usual training
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4 half-day of simulator ERCP practice as endoscopist and/or assistant followed by usual training
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Evaluation of trainee skills included success of diagnostic CBD and deep CBD cannulation
大体时间:3 months
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3 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Trainer blinded to the randomization provided assessment of each trainee performed ERCP
大体时间:3 months
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3 months
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合作者和调查者
出版物和有用的链接
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 (估计)
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
其他研究编号
- 200804030R
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