AzTrials
AzTrials

Simulation TrainingNCT03248453

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

A study testing CoPS in people with Simulation Training and Education, Medical, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Simulation Training, Education, Medical
What is being tested?
CoPS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteDenmark
Study dates
Dec 2016to 28 Feb 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Physicians
  • No endoscopic experience

Who cannot join

  • Non-physicians
  • Previous experience with endoscopy

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Copenhagen Acedemy of Medical Education and Simulation

    Copenhagen, 2100

Other trials in Denmark

About this study

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

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.

Read the 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.
Being tested
CoPS
Keywords
Simulated colonoscopy, Self-regulated learning

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03248453
Study groupRoleWhat they receive
CoPS feedbackExperimentalEach 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.
Receives: Other: CoPS
No CoPS feedbackNo interventionNo feedback is given and the participants are not aware of the CoPS

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: There is only one time point (baseline = after the final cases)

Secondary outcomes (2)

  1. Total time spent practicing

    Difference in total time spent practicing between groups

    Measured: up to 120 minutes

  2. Amount of time spend on each case

    Time spent practicing on case 2 versus time spent practicing on case 4

    Measured: up to 720 seconds

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2017
  2. Study startDec 2016
  3. Primary completion28 Feb 2017
  4. Study completion28 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03248453
Sponsor's protocol ID
COPS/self-regulated feedback
Status last verified
Aug 2017
First submitted
13 Oct 2016
Last updated
14 Aug 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21409379

  • 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.

    PubMed 25257129

  • 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.

    PubMed 22726473

  • 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.

    PubMed 22042592

  • 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.

    PubMed 23295321

  • 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.

    PubMed 15810775

  • 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.

    PubMed 23331720

  • 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.

    PubMed 30031803

Questions about this trial

What is this clinical trial studying?

A study testing CoPS in people with Simulation Training and Education, Medical, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Final CoPS (time frame: There is only one time point (baseline = after the final cases)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03248453, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2017.

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