Feedback Given by an Automatic and Objective System in Simulated Colonoscopy Increase Learning and Time Spent Practicing

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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: 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. Control group is not given any CoPS.

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

Conditions
-----------------
Simulation Training, Education, Medical

Intervention / Treatment
-----------------
* Other: CoPS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physicians No endoscopic experience Exclusion Criteria: Non-physicians Previous experience with endoscopy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CoPS feedback<br>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. | Other: CoPS<br>* The COPS is an automated and objective computer-based program which generate a score/number after the colonoscope has reached the cecum. The participants are able to compare the score with experts.<br>|
| No Intervention: No CoPS feedback<br>No feedback is given and the participants are not aware of the CoPS | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final CoPS | 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. | There is only one time point (baseline = after the final cases) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total time spent practicing | Difference in total time spent practicing between groups | up to 120 minutes | 
| Amount of time spend on each case | Time spent practicing on case 2 versus time spent practicing on case 4 | up to 720 seconds | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Simulated colonoscopy, Self-regulated learning