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临床试验/NCT03248453
NCT03248453已完成不适用

Do Feedback Given by an Automatic and Objective System in Simulated Colonoscopy Increase Learning and Time Spent Practicing? A Randomized Trial

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2016年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
Final CoPS

研究概览

简要总结

The aim is to investigate if feedback given by an automatic and objective system in simulated colonoscopy (the investigation of the large intestine) increase learning and time spent practicing.

详细描述

A standardized Kagaku Colonoscopy Training Model (Kyoto Kagaku Co Ltd, Kyoto, Japan) in combination with an Olympus colonoscope, a monitor and a Magnetic Endoscope Imaging (MEI) Scope Guide (Olympus Medical systems Corp) is used. The Kyoto Kagaku Colonoscope Training Model is a phantom model in full-size of the human colon. The model consists of an abdomen model, a soft and flexible rubber colon, anal sphincter opening and an abdomen skin cover. The rubber colon provides a realistic life-like response, which makes the participants able to feel when the colonoscope stretch and bent the rubber colon. To reduce friction between the rubber colon and the colonoscope a lubricant gels is applied inside the rubber colon. By hand pump the anal sphincter is manipulated, allowing insufflation and suction. Six different cases with different level of difficulty are possible. We chose case 2 (simple layout, but a long sigmoid colon) and case 4 (a challenging layout, with a difficult-to-shorten sigmoid colon and a drooping transverse colon) for training cases. Case 3 (simple layout, but with a naturally formed "Alpha" loop in the sigmoid colon) is chosen for the final test.

Experts - 10 experts, defined by the number of colonoscopies in total (> 1000), colonoscopies done within the last year (> 150) and locally considered among the best, will be recruited voluntarily. The experts are introduced to the Colonoscopy Training Model and allowed 15 minutes of practices before tests is recorded. With the exception of the first expert who is given the best Colonoscopy Progression Score (CoPS) executed by an instructor, the experts are shown the other experts top scores for each case as a motivation. Each expert carries out three different cases: Case 2, 3 and 4. Time for each case are 15 minutes.

Novices - 44 novices (interns and junior residents) with no experience in colonoscopy will be enrolled through a volunteer application form in the study. All novices will be handed written information about colonoscopy in general and basics. Novices will be introduced to the technical characteristics of the colonoscope by an instructor and allowed training for 15 minutes before the data collection is started. No feedback (from instructors) will be given during the training. Instructors will start data collection with introduction of the colonoscope into the anus and the data collection is stopped when the cecum is reached. For training the novices will have a free choice between case 2 and 4. Each novice is given the opportunity to redo the training for as long as they like before they believe to be ready for the final case. Case 3 will be used for the final test and all participants are to complete the case tree times.

Novices will be randomized into two groups:

  1. The intervention group is given feedback; presented with the CoPS after each time they reach cecum. A leaderboard, presenting all the experts CoPS, for comparison and motivation will be present next to the phantom model.
  2. Control group is not given any CoPS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

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

  • •Physicians
  • •No endoscopic experience

排除标准

  • •Non-physicians
  • •Previous experience with endoscopy

研究组 & 干预措施

CoPS feedback

Experimental

Each participant will as feedback be given the actual CoPS after reaching the cecum on the standardized Kagaku Training Model. A leaderboard with experts performances will be present for comparison.

干预措施: CoPS (Other)

No CoPS feedback

No Intervention

No feedback is given and the participants are not aware of the CoPS

结局指标

主要结局

Final CoPS

时间窗: There is only one time point (baseline = after the final cases)

The final CoPS is a mean-score of the CoPS´ in the final cases. Primary outcome is the difference between the interventiongroup and the control group.

次要结局

  • Total time spent practicing(up to 120 minutes)
  • Amount of time spend on each case(up to 720 seconds)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andreas Slot Vilmann

MD. Andreas Slot Vilmann

Rigshospitalet, Denmark

研究点 (1)

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