<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/NCT04401306</url>
  </required_header>
  <id_info>
    <org_study_id>sbs_au235143</org_study_id>
    <nct_id>NCT04401306</nct_id>
  </id_info>
  <brief_title>Remote Training in Laparoscopy</brief_title>
  <official_title>Remote Training in Laparoscopy: A Randomized Trial Comparing Home-based Self-regulated Training to Centralized Instructor-regulated Training.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Central Denmark Region</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northern Denmark Region</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>KARL STORZ Endoscopy Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aarhus</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 study is a prospective, randomized comparative study using a mixed methods design. The&#xD;
      primary objective is to compare the effect of self-regulated simulation training (SRST) to&#xD;
      instructor-regulated simulation training (IRST) in basic laparoscopic skills. The study&#xD;
      population is first-year trainees in the specialties General Surgery, Urology and Obstetrics&#xD;
      and Gynaecology within the postgraduate training region of northern Denmark. 46 first-year&#xD;
      trainees will be randomized into two groups, one receiving SRST and one receiving IRST in&#xD;
      basic laparoscopic skills.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 31, 2020</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean time for laparoscopic skills test (LASTT).</measure>
    <time_frame>0-7 months</time_frame>
    <description>Laparoscopic skills testing models (pre-test, post-test and retention-test). Scoring based on mean timing of 3 consecutively performed exercises (0-180 secs). Low time-scores are better than high time scores.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Test-score SUTT</measure>
    <time_frame>1-7 months</time_frame>
    <description>Laparoscopic knot tying testing model (post-test and retention test). Blinded outcome assessor. Score based on timing and quality of sutures and stitches (score range -2 to 18). High score is better than low score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Training time</measure>
    <time_frame>6-8 weeks</time_frame>
    <description>Accumulated raw training time (mins)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Training distribution</measure>
    <time_frame>6-8 weeks</time_frame>
    <description>Number of training sessions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pass-rates</measure>
    <time_frame>6-8 weeks</time_frame>
    <description>Pass/failure of proficiency-based training program (binary)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Interview</measure>
    <time_frame>0-3 months</time_frame>
    <description>Qualitative data: Semi-structured interviews</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Educational Problems</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Self-regulated simulation training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Instructor-regulated simulation training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home-based self-regulated simulation training (SRST)</intervention_name>
    <description>Participants allocated to the SRST arm train basic laparoscopic skills at home. Participants train by themselves using a portable box training model (BT). Training is conducted and structured through an online application-based training platform. Training is instructed by online instructional videos and texts. The BT is connected to a laptop and the participants can submit videos of their training exercises for assessment through the online training platform.</description>
    <arm_group_label>Self-regulated simulation training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Centralized instructor-regulated simulation training (IRST)</intervention_name>
    <description>Participants allocated to the IRST arm train basic laparoscopic skills at the simulation centre. Participants train on a portable box training model (BT). Training is structured through an online application-based training platform and facilitated and instructed by surgical specialists. The BT is connected to a laptop and the participants can submit videos of their training exercises for assessment through the online training platform.</description>
    <arm_group_label>Instructor-regulated simulation training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is a medical doctor&#xD;
&#xD;
          -  Participant is a first-year trainee in abdominal surgery, urology, or gynaecology and&#xD;
             obstetrics.&#xD;
&#xD;
          -  Participant is willing and able to give informed consent for participation in the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Performed &gt; 50 lap procedures prior to enrollment&#xD;
&#xD;
          -  participated in training programs provided by the former course provider in the&#xD;
             postgraduate training region of northern Denmark&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sigurd B Sloth, MD, PhD fellow</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre for Health Sciences Education, Aarhus University, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Health Sciences Education, Aarhus University</name>
      <address>
        <city>Aarhus</city>
        <state>Danmark</state>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 13, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>February 11, 2021</last_update_submitted>
  <last_update_submitted_qc>February 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Education</keyword>
  <keyword>Simulation</keyword>
  <keyword>Surgery</keyword>
  <keyword>Transfer</keyword>
  <keyword>Self-regulated learning</keyword>
  <keyword>Gynecology</keyword>
  <keyword>Urology</keyword>
  <keyword>Laparoscopy</keyword>
  <keyword>Home</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04401306
org study id: sbs_au235143
nct id: NCT04401306
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is a prospective, randomized comparative study using a mixed methods design. The
      primary objective is to compare the effect of self-regulated simulation training (SRST) to
      instructor-regulated simulation training (IRST) in basic laparoscopic skills. The study
      population is first-year trainees in the specialties General Surgery, Urology and Obstetrics
      and Gynaecology within the postgraduate training region of northern Denmark. 46 first-year
      trainees will be randomized into two groups, one receiving SRST and one receiving IRST in
      basic laparoscopic skills.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Mean time for laparoscopic skills test (LASTT).
time frame: 0-7 months
description: Laparoscopic skills testing models (pre-test, post-test and retention-test). Scoring based on mean timing of 3 consecutively performed exercises (0-180 secs). Low time-scores are better than high time scores.
measure: Test-score SUTT
time frame: 1-7 months
description: Laparoscopic knot tying testing model (post-test and retention test). Blinded outcome assessor. Score based on timing and quality of sutures and stitches (score range -2 to 18). High score is better than low score.
measure: Training time
time frame: 6-8 weeks
description: Accumulated raw training time (mins)
measure: Training distribution
time frame: 6-8 weeks
description: Number of training sessions
measure: Pass-rates
time frame: 6-8 weeks
description: Pass/failure of proficiency-based training program (binary)
measure: Interview
time frame: 0-3 months
description: Qualitative data: Semi-structured interviews
arm group label: Self-regulated simulation training
arm group type: Experimental
arm group label: Instructor-regulated simulation training
arm group type: Active Comparator
intervention type: Other
intervention name: Home-based self-regulated simulation training (SRST)
description: Participants allocated to the SRST arm train basic laparoscopic skills at home. Participants train by themselves using a portable box training model (BT). Training is conducted and structured through an online application-based training platform. Training is instructed by online instructional videos and texts. The BT is connected to a laptop and the participants can submit videos of their training exercises for assessment through the online training platform.
arm group label: Self-regulated simulation training
intervention type: Other
intervention name: Centralized instructor-regulated simulation training (IRST)
description: Participants allocated to the IRST arm train basic laparoscopic skills at the simulation centre. Participants train on a portable box training model (BT). Training is structured through an online application-based training platform and facilitated and instructed by surgical specialists. The BT is connected to a laptop and the participants can submit videos of their training exercises for assessment through the online training platform.
arm group label: Instructor-regulated simulation training
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Sigurd B Sloth, MD, PhD fellow
role: Principal Investigator
affiliation: Centre for Health Sciences Education, Aarhus University, Denmark
facility: 
country: Denmark
responsible party type: Sponsor
sharing ipd: Undecided