<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03248453</url>
  </required_header>
  <id_info>
    <org_study_id>COPS/self-regulated feedback</org_study_id>
    <nct_id>NCT03248453</nct_id>
  </id_info>
  <brief_title>Feedback Given by an Automatic and Objective System in Simulated Colonoscopy Increase Learning and Time Spent Practicing</brief_title>
  <official_title>Do Feedback Given by an Automatic and Objective System in Simulated Colonoscopy Increase Learning and Time Spent Practicing? A Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Technical University of Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim is to investigate if feedback given by an automatic and objective system in simulated&#xD;
      colonoscopy (the investigation of the large intestine) increase learning and time spent&#xD;
      practicing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A standardized Kagaku Colonoscopy Training Model (Kyoto Kagaku Co Ltd, Kyoto, Japan) in&#xD;
      combination with an Olympus colonoscope, a monitor and a Magnetic Endoscope Imaging (MEI)&#xD;
      Scope Guide (Olympus Medical systems Corp) is used. The Kyoto Kagaku Colonoscope Training&#xD;
      Model is a phantom model in full-size of the human colon. The model consists of an abdomen&#xD;
      model, a soft and flexible rubber colon, anal sphincter opening and an abdomen skin cover.&#xD;
      The rubber colon provides a realistic life-like response, which makes the participants able&#xD;
      to feel when the colonoscope stretch and bent the rubber colon. To reduce friction between&#xD;
      the rubber colon and the colonoscope a lubricant gels is applied inside the rubber colon. By&#xD;
      hand pump the anal sphincter is manipulated, allowing insufflation and suction. Six different&#xD;
      cases with different level of difficulty are possible. We chose case 2 (simple layout, but a&#xD;
      long sigmoid colon) and case 4 (a challenging layout, with a difficult-to-shorten sigmoid&#xD;
      colon and a drooping transverse colon) for training cases. Case 3 (simple layout, but with a&#xD;
      naturally formed &quot;Alpha&quot; loop in the sigmoid colon) is chosen for the final test.&#xD;
&#xD;
      Experts - 10 experts, defined by the number of colonoscopies in total (&gt; 1000), colonoscopies&#xD;
      done within the last year (&gt; 150) and locally considered among the best, will be recruited&#xD;
      voluntarily. The experts are introduced to the Colonoscopy Training Model and allowed 15&#xD;
      minutes of practices before tests is recorded. With the exception of the first expert who is&#xD;
      given the best Colonoscopy Progression Score (CoPS) executed by an instructor, the experts&#xD;
      are shown the other experts top scores for each case as a motivation. Each expert carries out&#xD;
      three different cases: Case 2, 3 and 4. Time for each case are 15 minutes.&#xD;
&#xD;
      Novices - 44 novices (interns and junior residents) with no experience in colonoscopy will be&#xD;
      enrolled through a volunteer application form in the study. All novices will be handed&#xD;
      written information about colonoscopy in general and basics. Novices will be introduced to&#xD;
      the technical characteristics of the colonoscope by an instructor and allowed training for 15&#xD;
      minutes before the data collection is started. No feedback (from instructors) will be given&#xD;
      during the training. Instructors will start data collection with introduction of the&#xD;
      colonoscope into the anus and the data collection is stopped when the cecum is reached. For&#xD;
      training the novices will have a free choice between case 2 and 4. Each novice is given the&#xD;
      opportunity to redo the training for as long as they like before they believe to be ready for&#xD;
      the final case. Case 3 will be used for the final test and all participants are to complete&#xD;
      the case tree times.&#xD;
&#xD;
      Novices will be randomized into two groups:&#xD;
&#xD;
        1. The intervention group is given feedback; presented with the CoPS after each time they&#xD;
           reach cecum. A leaderboard, presenting all the experts CoPS, for comparison and&#xD;
           motivation will be present next to the phantom model.&#xD;
&#xD;
        2. Control group is not given any CoPS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">February 28, 2017</completion_date>
  <primary_completion_date type="Actual">February 28, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Final CoPS</measure>
    <time_frame>There is only one time point (baseline = after the final cases)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total time spent practicing</measure>
    <time_frame>up to 120 minutes</time_frame>
    <description>Difference in total time spent practicing between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of time spend on each case</measure>
    <time_frame>up to 720 seconds</time_frame>
    <description>Time spent practicing on case 2 versus time spent practicing on case 4</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Simulation Training</condition>
  <condition>Education, Medical</condition>
  <arm_group>
    <arm_group_label>CoPS feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No CoPS feedback</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No feedback is given and the participants are not aware of the CoPS</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CoPS</intervention_name>
    <description>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.</description>
    <arm_group_label>CoPS feedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Physicians&#xD;
&#xD;
          -  No endoscopic experience&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-physicians&#xD;
&#xD;
          -  Previous experience with endoscopy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lars Konge, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>CAMES-Rigshospitalet, Copenhagen Academy for Medical Education and Simulation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Copenhagen Acedemy of Medical Education and Simulation</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>21409379</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25257129</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22726473</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22042592</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23295321</PMID>
  </reference>
  <reference>
    <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>
    <PMID>15810775</PMID>
  </reference>
  <reference>
    <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>
    <PMID>23331720</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>October 13, 2016</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>August 11, 2017</last_update_submitted>
  <last_update_submitted_qc>August 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Andreas Slot Vilmann</investigator_full_name>
    <investigator_title>MD. Andreas Slot Vilmann</investigator_title>
  </responsible_party>
  <keyword>Simulated colonoscopy</keyword>
  <keyword>Self-regulated learning</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03248453
org study id: COPS/self-regulated feedback
nct id: NCT03248453
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Final CoPS
time frame: There is only one time point (baseline = after the final cases)
description: 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.
measure: Total time spent practicing
time frame: up to 120 minutes
description: Difference in total time spent practicing between groups
measure: Amount of time spend on each case
time frame: up to 720 seconds
description: Time spent practicing on case 2 versus time spent practicing on case 4
arm group label: CoPS feedback
arm group type: Experimental
description: 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.
arm group label: No CoPS feedback
arm group type: No Intervention
description: No feedback is given and the participants are not aware of the CoPS
intervention type: Other
intervention name: CoPS
description: 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.
arm group label: CoPS feedback
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lars Konge, Professor
role: Principal Investigator
affiliation: CAMES-Rigshospitalet, Copenhagen Academy for Medical Education and Simulation
facility: 
country: Denmark
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.
PMID: 21409379
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.
PMID: 25257129
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.
PMID: 22726473
citation: 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: 22042592
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.
PMID: 23295321
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.
PMID: 15810775
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.
PMID: 23331720
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Andreas Slot Vilmann
investigator title: MD. Andreas Slot Vilmann
sharing ipd: No