<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/NCT02243215</url>
  </required_header>
  <id_info>
    <org_study_id>TABLT 2 Offsite</org_study_id>
    <secondary_id>REG-68-2014</secondary_id>
    <nct_id>NCT02243215</nct_id>
  </id_info>
  <brief_title>Off-site Training in Laparoscopy</brief_title>
  <official_title>Off-site vs. On-site Simulation Training in Laparoscopy a Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zealand University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Region Capital Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Zealand University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a randomized study exploring the difference between off-site vs. on-site&#xD;
      training in laparoscopic skills. The study will be performed using fifty surgical trainees&#xD;
      from the departments of urology, surgery and gynecology. The participants will be recruited,&#xD;
      enrolled and randomized during the introductory course in basic laparoscopic techniques held&#xD;
      six times annually at Center of Clinical Education(CEKU).&#xD;
&#xD;
      Participants will be able to train laparoscopic skills on a Box Trainer(BT) and on a Virtual&#xD;
      Reality Simulator(VRS). They will practice until they reach a predefined level of proficiency&#xD;
      on seven basic modules, the procedure module; &quot;salpingectomy&quot; on the LapSim™ and reach the&#xD;
      passing level of 358pts on the Training and Assessment of Basic Laparoscopic&#xD;
      Techniques(TABLT) technical test.&#xD;
&#xD;
      The intervention group will have a portable trainer available to allow training at their&#xD;
      convenience, be it at home or at work. The control group will only practice on-site at CEKU&#xD;
      and at their local hospital.&#xD;
&#xD;
      Participants will be asked to keep a training log with details of time spend on training and&#xD;
      number of training sessions. The training log will contain information on any type practice&#xD;
      involving laparoscopy be it on a BT or a VRS at the local hospital, at home on the tablet&#xD;
      trainer or training at CEKU. Also time spend in the operation room, assisting or performing&#xD;
      laparoscopic surgery will be registered.&#xD;
&#xD;
      To pass the TABLT all participants will book a test session at CEKU for their final test at&#xD;
      the end of their training. At the test sessions TABLT test scores will be established on site&#xD;
      by the Chief Investigator and afterwards using video recordings of the test. A blinded rater&#xD;
      will give scores based on the video recordings and this will be the decisive rating to&#xD;
      determine whether the participant has passed the test.&#xD;
&#xD;
      To pass the VRS training an employee at CEKU will monitor a VRS practice session in which&#xD;
      proficiency level is reached.&#xD;
&#xD;
      The enrollment of participants is expected to finish June 2015 a data analysis will be&#xD;
      performed in July 2015.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in time(days) to reach a defined proficiency level(358pts) on the TABLT technical test.</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Trainees use of off-site training in laparoscopic surgery</measure>
    <time_frame>6 months</time_frame>
    <description>Qualitative focus group interviews, individual interviews and log-books</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in time(mins.) used on training to reach a defined proficiency level(358pts) on the TABLT technical test.</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the number of training sessions used to reach a defined proficiency level(358pts) on the TABLT technical test.</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in time(days) to reach a defined proficiency level on seven basic tasks and the salpingectomy module on the Lap Sim(R).</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in time(mins.) used on training to reach a defined proficiency level on seven basic tasks and the salpingectomy module on the Lap Sim(R).</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in number of training sessions used to reach a defined proficiency level on seven basic tasks and the salpingectomy module on the Lap Sim(R).</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between participants rating of pre-tests and a blinded rater</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Difference in number of laparoscopic surgeries in 6 month period after having passed the TABLT test and reached a defined proficiency level on seven basic tasks and the salpingectomy module on the Lap Sim(R).</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Difference in test score on the TABLT technical test.</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Difference in number of laparoscopic surgeries during the training period, from enrollment to having passed the TABLT test</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Off-site Training in Laparoscopy</condition>
  <arm_group>
    <arm_group_label>Offsite training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Access to a portable trainer for laparoscopic skills</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Onsite training</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Will be able practice on-site at Center of Clinical Education and at their local hospital.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Access to a portable trainer for laparoscopic skills</intervention_name>
    <description>Participants will have a portable trainer available to allow training at their convenience, and will be able practice on-site at Center of Clinical Education and at their local hospital.</description>
    <arm_group_label>Offsite training</arm_group_label>
    <other_name>Laptap(R)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is willing and able to give informed consent for participation in the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hey have performed more than 50 laparoscopic procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ebbe Thinggaard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zealand University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Clinical Education</name>
      <address>
        <city>Copenhagen</city>
        <state>Capital Region</state>
        <zip>2200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <reference>
    <citation>Korndorffer JR Jr, Bellows CF, Tekian A, Harris IB, Downing SM. Effective home laparoscopic simulation training: a preliminary evaluation of an improved training paradigm. Am J Surg. 2012 Jan;203(1):1-7. doi: 10.1016/j.amjsurg.2011.07.001.</citation>
    <PMID>22172481</PMID>
  </reference>
  <reference>
    <citation>Ericsson KA. Deliberate practice and the acquisition and maintenance of expert performance in medicine and related domains. Acad Med. 2004 Oct;79(10 Suppl):S70-81. doi: 10.1097/00001888-200410001-00022. No abstract available.</citation>
    <PMID>15383395</PMID>
  </reference>
  <reference>
    <citation>Gallagher AG, Jordan-Black JA, O'Sullivan GC. Prospective, randomized assessment of the acquisition, maintenance, and loss of laparoscopic skills. Ann Surg. 2012 Aug;256(2):387-93. doi: 10.1097/SLA.0b013e318251f3d2.</citation>
    <PMID>22580935</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>Snyder CW, Vandromme MJ, Tyra SL, Hawn MT. Proficiency-based laparoscopic and endoscopic training with virtual reality simulators: a comparison of proctored and independent approaches. J Surg Educ. 2009 Jul-Aug;66(4):201-7. doi: 10.1016/j.jsurg.2009.07.007.</citation>
    <PMID>19896624</PMID>
  </reference>
  <reference>
    <citation>Kahol K, Leyba MJ, Deka M, Deka V, Mayes S, Smith M, Ferrara JJ, Panchanathan S. Effect of fatigue on psychomotor and cognitive skills. Am J Surg. 2008 Feb;195(2):195-204. doi: 10.1016/j.amjsurg.2007.10.004.</citation>
    <PMID>18194679</PMID>
  </reference>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>October 19, 2015</last_update_submitted>
  <last_update_submitted_qc>October 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zealand University Hospital</investigator_affiliation>
    <investigator_full_name>Ebbe Thinggaard</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>Laparoscopy</keyword>
  <keyword>Training</keyword>
  <keyword>Off-site</keyword>
  <keyword>Box trainer</keyword>
  <keyword>Virtual Reality Simulator</keyword>
  <pending_results>
    <submitted>August 1, 2017</submitted>
    <returned>February 5, 2018</returned>
  </pending_results>
  <!-- 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/NCT02243215
org study id: TABLT 2 Offsite
secondary id: REG-68-2014
nct id: NCT02243215
lead sponsor: 
collaborator: 
has dmc: Yes
The study is a randomized study exploring the difference between off-site vs. on-site
      training in laparoscopic skills. The study will be performed using fifty surgical trainees
      from the departments of urology, surgery and gynecology. The participants will be recruited,
      enrolled and randomized during the introductory course in basic laparoscopic techniques held
      six times annually at Center of Clinical Education(CEKU).

      Participants will be able to train laparoscopic skills on a Box Trainer(BT) and on a Virtual
      Reality Simulator(VRS). They will practice until they reach a predefined level of proficiency
      on seven basic modules, the procedure module; "salpingectomy" on the LapSim™ and reach the
      passing level of 358pts on the Training and Assessment of Basic Laparoscopic
      Techniques(TABLT) technical test.

      The intervention group will have a portable trainer available to allow training at their
      convenience, be it at home or at work. The control group will only practice on-site at CEKU
      and at their local hospital.

      Participants will be asked to keep a training log with details of time spend on training and
      number of training sessions. The training log will contain information on any type practice
      involving laparoscopy be it on a BT or a VRS at the local hospital, at home on the tablet
      trainer or training at CEKU. Also time spend in the operation room, assisting or performing
      laparoscopic surgery will be registered.

      To pass the TABLT all participants will book a test session at CEKU for their final test at
      the end of their training. At the test sessions TABLT test scores will be established on site
      by the Chief Investigator and afterwards using video recordings of the test. A blinded rater
      will give scores based on the video recordings and this will be the decisive rating to
      determine whether the participant has passed the test.

      To pass the VRS training an employee at CEKU will monitor a VRS practice session in which
      proficiency level is reached.

      The enrollment of participants is expected to finish June 2015 a data analysis will be
      performed in July 2015.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Difference in time(days) to reach a defined proficiency level(358pts) on the TABLT technical test.
time frame: 6 months
measure: Trainees use of off-site training in laparoscopic surgery
time frame: 6 months
description: Qualitative focus group interviews, individual interviews and log-books
measure: Difference in time(mins.) used on training to reach a defined proficiency level(358pts) on the TABLT technical test.
time frame: 6 months
measure: Difference in the number of training sessions used to reach a defined proficiency level(358pts) on the TABLT technical test.
time frame: 6 months
measure: Difference in time(days) to reach a defined proficiency level on seven basic tasks and the salpingectomy module on the Lap Sim(R).
time frame: 6 months
measure: Difference in time(mins.) used on training to reach a defined proficiency level on seven basic tasks and the salpingectomy module on the Lap Sim(R).
time frame: 6 months
measure: Difference in number of training sessions used to reach a defined proficiency level on seven basic tasks and the salpingectomy module on the Lap Sim(R).
time frame: 6 months
measure: Correlation between participants rating of pre-tests and a blinded rater
time frame: 6 months
measure: Difference in number of laparoscopic surgeries in 6 month period after having passed the TABLT test and reached a defined proficiency level on seven basic tasks and the salpingectomy module on the Lap Sim(R).
time frame: 6 months
measure: Difference in test score on the TABLT technical test.
time frame: 6 months
measure: Difference in number of laparoscopic surgeries during the training period, from enrollment to having passed the TABLT test
time frame: 6 months
arm group label: Offsite training
arm group type: Experimental
description: Access to a portable trainer for laparoscopic skills
arm group label: Onsite training
arm group type: No Intervention
description: Will be able practice on-site at Center of Clinical Education and at their local hospital.
intervention type: Other
intervention name: Access to a portable trainer for laparoscopic skills
description: Participants will have a portable trainer available to allow training at their convenience, and will be able practice on-site at Center of Clinical Education and at their local hospital.
arm group label: Offsite training
other name: Laptap(R)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ebbe Thinggaard, MD
role: Principal Investigator
affiliation: Zealand University Hospital
facility: 
country: Denmark
citation: Korndorffer JR Jr, Bellows CF, Tekian A, Harris IB, Downing SM. Effective home laparoscopic simulation training: a preliminary evaluation of an improved training paradigm. Am J Surg. 2012 Jan;203(1):1-7. doi: 10.1016/j.amjsurg.2011.07.001.
PMID: 22172481
citation: Ericsson KA. Deliberate practice and the acquisition and maintenance of expert performance in medicine and related domains. Acad Med. 2004 Oct;79(10 Suppl):S70-81. doi: 10.1097/00001888-200410001-00022. No abstract available.
PMID: 15383395
citation: Gallagher AG, Jordan-Black JA, O'Sullivan GC. Prospective, randomized assessment of the acquisition, maintenance, and loss of laparoscopic skills. Ann Surg. 2012 Aug;256(2):387-93. doi: 10.1097/SLA.0b013e318251f3d2.
PMID: 22580935
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: Snyder CW, Vandromme MJ, Tyra SL, Hawn MT. Proficiency-based laparoscopic and endoscopic training with virtual reality simulators: a comparison of proctored and independent approaches. J Surg Educ. 2009 Jul-Aug;66(4):201-7. doi: 10.1016/j.jsurg.2009.07.007.
PMID: 19896624
citation: Kahol K, Leyba MJ, Deka M, Deka V, Mayes S, Smith M, Ferrara JJ, Panchanathan S. Effect of fatigue on psychomotor and cognitive skills. Am J Surg. 2008 Feb;195(2):195-204. doi: 10.1016/j.amjsurg.2007.10.004.
PMID: 18194679
responsible party type: Principal Investigator
investigator affiliation: Zealand University Hospital
investigator full name: Ebbe Thinggaard
investigator title: Medical Doctor
submitted: August 1, 2017
returned: February 5, 2018