Clinical trial NCT03248453: Feedback Given by an Automatic and Objective System in Simulated Colonoscopy Increase Learning and Time Spent Practicing
Official title: Do Feedback Given by an Automatic and Objective System in Simulated Colonoscopy Increase Learning and Time Spent Practicing? A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Simulation Training
Education, Medical
Keywords: Simulated colonoscopy
Self-regulated learning
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Technical University of Denmark
First posted: 2017-08-14
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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:

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.

Eligibility criteria: Inclusion Criteria:

* Physicians
* No endoscopic experience

Exclusion Criteria:

* Non-physicians
* Previous experience with endoscopy

Primary outcomes:
measure: Final CoPS
timeFrame: There is only one time point (baseline = after the final cases)
Secondary outcomes:
measure: Total time spent practicing
timeFrame: up to 120 minutes
measure: Amount of time spend on each case
timeFrame: up to 720 seconds
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen Acedemy of Medical Education and Simulation
Study officials:
affiliation: CAMES-Rigshospitalet, Copenhagen Academy for Medical Education and Simulation
name: Lars Konge, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Wulf G, Raupach M, Pfeiffer F. Self-controlled observational practice enhances learning. Res Q Exerc Sport. 2005 Mar;76(1):107-11. doi: 10.1080/02701367.2005.10599266. No abstract available.
citation: Park HJ, Hong JH, Kim HS, Kim BR, Park SY, Jo KW, Kim JW. Predictive factors affecting cecal intubation failure in colonoscopy trainees. BMC Med Educ. 2013 Jan 19;13:5. doi: 10.1186/1472-6920-13-5.
citation: Vilmann AS, Norsk D, Svendsen MBS, Reinhold R, Svendsen LB, Park YS, Konge L. Computerized feedback during colonoscopy training leads to improved performance: a randomized trial. Gastrointest Endosc. 2018 Nov;88(5):869-876. doi: 10.1016/j.gie.2018.07.008. Epub 2018 Jul 19.