NCT03248453

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 14, 2017

Completed
Last Updated

August 14, 2017

Status Verified

August 1, 2017

Enrollment Period

3 months

First QC Date

October 13, 2016

Last Update Submit

August 11, 2017

Conditions

Simulation TrainingEducation, Medical

Keywords

Simulated colonoscopySelf-regulated learning

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Total time spent practicing

    up to 120 minutes

  • Amount of time spend on each case

    up to 720 seconds

Study Arms (2)

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.

Other: CoPS

No CoPS feedback

NO INTERVENTION

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

Interventions

CoPSOTHER

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.

CoPS feedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physicians
  • No endoscopic experience

You may not qualify if:

  • Non-physicians
  • Previous experience with endoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen Acedemy of Medical Education and Simulation

Copenhagen, 2100, Denmark

Location

Related Publications (8)

  • 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.

    PMID: 21409379BACKGROUND

  • 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.

    PMID: 25257129BACKGROUND

  • 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.

    PMID: 22726473BACKGROUND

  • 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.

    PMID: 22042592BACKGROUND

  • 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.

    PMID: 23295321BACKGROUND

  • 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.

    PMID: 15810775BACKGROUND

  • 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.

    PMID: 23331720BACKGROUND

  • 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.

    PMID: 30031803DERIVED

Study Officials

  • Lars Konge, Professor

    CAMES-Rigshospitalet, Copenhagen Academy for Medical Education and Simulation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. Andreas Slot Vilmann

Study Record Dates

First Submitted

October 13, 2016

First Posted

August 14, 2017

Study Start

December 1, 2016

Primary Completion

February 28, 2017

Study Completion

February 28, 2017

Last Updated

August 14, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)