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

Simulation Training Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03248453
• Other study ID #: COPS/self-regulated feedback
• Status: Completed
• Phase: N/A
• First received: October 13, 2016
• Last updated: August 11, 2017
• Start date: December 2016
• Est. completion date: February 28, 2017

Study information

• Verified date: August 2017
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Physicians

• No endoscopic experience

Exclusion Criteria:

• Non-physicians

• Previous experience with endoscopy

Related Conditions & MeSH terms

• Education, Medical
• Simulation Training

Intervention

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.

Locations

Country	Name	City	State
Denmark	Copenhagen Acedemy of Medical Education and Simulation	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Technical University of Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (7)

Brinkman WM, Buzink SN, Alevizos L, de Hingh IH, Jakimowicz JJ. Criterion-based laparoscopic training reduces total training time. Surg Endosc. 2012 Apr;26(4):1095-101. doi: 10.1007/s00464-011-2005-6. Epub 2011 Nov 1. — View Citation

Kaltenbach T, Leung C, Wu K, Yan K, Friedland S, Soetikno R. Use of the colonoscope training model with the colonoscope 3D imaging probe improved trainee colonoscopy performance: a pilot study. Dig Dis Sci. 2011 May;56(5):1496-502. doi: 10.1007/s10620-011-1614-1. Epub 2011 Mar 16. — View Citation

Nerup N, Preisler L, Svendsen MB, Svendsen LB, Konge L. Assessment of colonoscopy by use of magnetic endoscopic imaging: design and validation of an automated tool. Gastrointest Endosc. 2015 Mar;81(3):548-54. doi: 10.1016/j.gie.2014.07.019. Epub 2014 Sep 23. — View 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. — View Citation

Plooy AM, Hill A, Horswill MS, Cresp AS, Watson MO, Ooi SY, Riek S, Wallis GM, Burgess-Limerick R, Hewett DG. Construct validation of a physical model colonoscopy simulator. Gastrointest Endosc. 2012 Jul;76(1):144-50. doi: 10.1016/j.gie.2012.03.246. — View Citation

Strandbygaard J, Bjerrum F, Maagaard M, Winkel P, Larsen CR, Ringsted C, Gluud C, Grantcharov T, Ottesen B, Sorensen JL. Instructor feedback versus no instructor feedback on performance in a laparoscopic virtual reality simulator: a randomized trial. Ann Surg. 2013 May;257(5):839-44. doi: 10.1097/SLA.0b013e31827eee6e. — View Citation

Wulf G, Raupach M, Pfeiffer F. Self-controlled observational practice enhances learning. Res Q Exerc Sport. 2005 Mar;76(1):107-11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total time spent practicing	Difference in total time spent practicing between groups	up to 120 minutes
Secondary	Amount of time spend on each case	Time spent practicing on case 2 versus time spent practicing on case 4	up to 720 seconds

External Links

•   The Kyoto Kagaku Training Model