<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/NCT03763903</url>
  </required_header>
  <id_info>
    <org_study_id>2018_123</org_study_id>
    <nct_id>NCT03763903</nct_id>
  </id_info>
  <brief_title>Comparison of the Effectiveness of 2D Versus 3D Basic Laparoscopic Skills Training</brief_title>
  <official_title>Comparison of 3D Versus 2D Training of Basic Laparoscopic Skills in Terms of Training Effectiveness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</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 of this study is to find out whether basic laparoscopic skills training (FLS tasks)&#xD;
      on a standard pelvic trainer using conventional 2D visualization is at least equally&#xD;
      effective in terms of skills improvement compared to practicing with 3D visualization.&#xD;
      Furthermore, the progress in basic laparoscopic skills improvement for each visualization&#xD;
      modality will be analyzed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An increasing number of operations are done minimal invasively. For example, appendectomy,&#xD;
      cholecystectomy, bariatric procedures, colorectal resections as well as hysterectomy and many&#xD;
      other gynecologic procedures, are routinely performed laparoscopically.&#xD;
&#xD;
      Laparoscopy requires psychomotor skills that may be difficult to learn and result in&#xD;
      prolonged learning curves. In order to become familiar with the 2-dimensional visualization&#xD;
      and to learn and improve laparoscopic skills, training is needed. As traditional training in&#xD;
      the operating room is expensive and comprises an increased operating risk for the patient,&#xD;
      various training alternatives outside the operating room have been developed and shown to be&#xD;
      effective in translating the thereby acquired skills to the operating room. Besides training&#xD;
      on live animals or cadavers, there are virtual reality simulators, augmented reality&#xD;
      simulators and different box trainers. Each of these training devices has specific advantages&#xD;
      and limitations. However, some types could be superior to others in terms of training&#xD;
      effectiveness. For instance, with implementation of 3D visualization during laparoscopic&#xD;
      interventions which facilitates spatial perception, the question arises as to whether&#xD;
      training of basic laparoscopic skills using conventional 2D visualization is at least equally&#xD;
      effective compared to training with 3D visualization.&#xD;
&#xD;
      The aim of this study is to find out whether basic laparoscopic skills (FLS tasks) training&#xD;
      on a standard pelvic trainer using conventional 2D visualization is at least equally&#xD;
      effective in terms of skills improvement compared to practicing with 3D visualization.&#xD;
      Furthermore, the progress in basic laparoscopic skills improvement for each visualization&#xD;
      modality will be analyzed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 13, 2018</start_date>
  <completion_date type="Actual">December 14, 2018</completion_date>
  <primary_completion_date type="Actual">December 14, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in total Fundamentals of Laparoscopic Surgery (FLS) manual skills scores using 2D versus 3D training of basic laparoscopic skills (using four different FLS tasks)</measure>
    <time_frame>5 weeks</time_frame>
    <description>Performance of four different Fundamentals of Laparoscopic Surgery (FLS) tasks will be assessed according to the time needed to complete the task as well as the accuracy of task performance using the FLS scoring system as previously described [Derossis AM, Fried GM, Abrahamowicz M, et al. Development of a model for training and evaluation of laparoscopic skills. Am J Surg 1998;175:482-7.]. The improvement of performance for the total score as well as for each FLS task will be calculated by subtracting the baseline test scores from the posttraining test scores. The primary outcome measure will be the improvement in total test scores.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progress in basic laparoscopic skills improvement according to the time required for completion of the different FLS tasks during the training period in the 3D and the 2D visualization group</measure>
    <time_frame>5 weeks</time_frame>
    <description>Analysis of the progress in basic laparoscopic skills improvement according to the time required for FLS task completion during the training period for each of the two visualization modalities</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Laparoscopy</condition>
  <arm_group>
    <arm_group_label>3D training</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Basic laparoscopic skills (FLS tasks) training using 3D visualization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2D training</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Basic laparoscopic skills (FLS tasks) training using 2D visualization</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>3D training</intervention_name>
    <description>Skills (FLS tasks) training using 3D visualization</description>
    <arm_group_label>3D training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>2D training</intervention_name>
    <description>Skills (FLS tasks) training using 2D visualization</description>
    <arm_group_label>2D training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  medical students with limited experience in laparoscopic surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any laparoscopic operation performed as the primary surgeon&#xD;
&#xD;
          -  regular (e.g., once per month) practice on a box trainer for the last 12 months&#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>Heinrich Husslein, MD, PLL.M.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Obstetrics and Gynecology, Medical University of Vienna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University Vienna</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 2, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>March 29, 2019</last_update_submitted>
  <last_update_submitted_qc>March 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Heinrich Husslein</investigator_full_name>
    <investigator_title>Assoc.-Prof. Priv.-Doz. Dr., PLL.M.</investigator_title>
  </responsible_party>
  <keyword>skills training</keyword>
  <keyword>laparoscopic surgery</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/NCT03763903
org study id: 2018_123
nct id: NCT03763903
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to find out whether basic laparoscopic skills training (FLS tasks)
      on a standard pelvic trainer using conventional 2D visualization is at least equally
      effective in terms of skills improvement compared to practicing with 3D visualization.
      Furthermore, the progress in basic laparoscopic skills improvement for each visualization
      modality will be analyzed.
An increasing number of operations are done minimal invasively. For example, appendectomy,
      cholecystectomy, bariatric procedures, colorectal resections as well as hysterectomy and many
      other gynecologic procedures, are routinely performed laparoscopically.

      Laparoscopy requires psychomotor skills that may be difficult to learn and result in
      prolonged learning curves. In order to become familiar with the 2-dimensional visualization
      and to learn and improve laparoscopic skills, training is needed. As traditional training in
      the operating room is expensive and comprises an increased operating risk for the patient,
      various training alternatives outside the operating room have been developed and shown to be
      effective in translating the thereby acquired skills to the operating room. Besides training
      on live animals or cadavers, there are virtual reality simulators, augmented reality
      simulators and different box trainers. Each of these training devices has specific advantages
      and limitations. However, some types could be superior to others in terms of training
      effectiveness. For instance, with implementation of 3D visualization during laparoscopic
      interventions which facilitates spatial perception, the question arises as to whether
      training of basic laparoscopic skills using conventional 2D visualization is at least equally
      effective compared to training with 3D visualization.

      The aim of this study is to find out whether basic laparoscopic skills (FLS tasks) training
      on a standard pelvic trainer using conventional 2D visualization is at least equally
      effective in terms of skills improvement compared to practicing with 3D visualization.
      Furthermore, the progress in basic laparoscopic skills improvement for each visualization
      modality will be analyzed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Improvement in total Fundamentals of Laparoscopic Surgery (FLS) manual skills scores using 2D versus 3D training of basic laparoscopic skills (using four different FLS tasks)
time frame: 5 weeks
description: Performance of four different Fundamentals of Laparoscopic Surgery (FLS) tasks will be assessed according to the time needed to complete the task as well as the accuracy of task performance using the FLS scoring system as previously described [Derossis AM, Fried GM, Abrahamowicz M, et al. Development of a model for training and evaluation of laparoscopic skills. Am J Surg 1998;175:482-7.]. The improvement of performance for the total score as well as for each FLS task will be calculated by subtracting the baseline test scores from the posttraining test scores. The primary outcome measure will be the improvement in total test scores.
measure: Progress in basic laparoscopic skills improvement according to the time required for completion of the different FLS tasks during the training period in the 3D and the 2D visualization group
time frame: 5 weeks
description: Analysis of the progress in basic laparoscopic skills improvement according to the time required for FLS task completion during the training period for each of the two visualization modalities
arm group label: 3D training
arm group type: Other
description: Basic laparoscopic skills (FLS tasks) training using 3D visualization
arm group label: 2D training
arm group type: Other
description: Basic laparoscopic skills (FLS tasks) training using 2D visualization
intervention type: Other
intervention name: 3D training
description: Skills (FLS tasks) training using 3D visualization
arm group label: 3D training
intervention type: Other
intervention name: 2D training
description: Skills (FLS tasks) training using 2D visualization
arm group label: 2D training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Heinrich Husslein, MD, PLL.M.
role: Principal Investigator
affiliation: Department of Obstetrics and Gynecology, Medical University of Vienna
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Heinrich Husslein
investigator title: Assoc.-Prof. Priv.-Doz. Dr., PLL.M.
sharing ipd: No