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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03248453
Recruitment Status : Completed
First Posted : August 14, 2017
Last Update Posted : August 14, 2017
Sponsor:
Collaborator:
Technical University of Denmark
Information provided by (Responsible Party):
Andreas Slot Vilmann, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment Phase
Simulation Training Education, Medical Other: CoPS Not Applicable

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:

  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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Do Feedback Given by an Automatic and Objective System in Simulated Colonoscopy Increase Learning and Time Spent Practicing? A Randomized Trial
Study Start Date : December 2016
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: CoPS feedback
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
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.

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



Primary Outcome Measures :
  1. Final CoPS [ Time Frame: 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.


Secondary Outcome Measures :
  1. Total time spent practicing [ Time Frame: up to 120 minutes ]
    Difference in total time spent practicing between groups

  2. Amount of time spend on each case [ Time Frame: up to 720 seconds ]
    Time spent practicing on case 2 versus time spent practicing on case 4



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Physicians
  • No endoscopic experience

Exclusion Criteria:

  • Non-physicians
  • Previous experience with endoscopy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248453


Locations
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Denmark
Copenhagen Acedemy of Medical Education and Simulation
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Technical University of Denmark
Investigators
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Principal Investigator: Lars Konge, Professor CAMES-Rigshospitalet, Copenhagen Academy for Medical Education and Simulation
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andreas Slot Vilmann, MD. Andreas Slot Vilmann, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03248453    
Other Study ID Numbers: COPS/self-regulated feedback
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andreas Slot Vilmann, Rigshospitalet, Denmark:
Simulated colonoscopy
Self-regulated learning