<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/NCT03758586</url>
  </required_header>
  <id_info>
    <org_study_id>0602-18-RMB</org_study_id>
    <nct_id>NCT03758586</nct_id>
  </id_info>
  <brief_title>Spatial Skill Training for Robot-assisted Surgery</brief_title>
  <official_title>An Efficient Single-Session Spatial Skill Trainer for Robot-assisted Surgery: A Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rambam Health Care Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rambam Health Care Campus</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>
      Surgical residents from a single tertiary medical center were divided into 2 groups. All&#xD;
      residents performed 2 tasks on a Da Vinci robotic simulator system after which they were&#xD;
      either given a real training session in spatial skills (study group) or shown a short&#xD;
      presentation regarding robotic surgery. After training/watching the presentation, they&#xD;
      repeated the for mentioned tasks on the robotic simulator. Improvement in surgeon&#xD;
      performance, especially regarding tissue damage was documented.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Importance: Robot-assisted surgery is becoming the mainstay of modern surgery. Efficient&#xD;
      training techniques are essential for enhanced performance. Optimal performance during a&#xD;
      surgical task is key to successful surgery and minimal adverse events.&#xD;
&#xD;
      Objective: To introduce and examine a single session of spatial skill training as an&#xD;
      efficient means of improving surgical suturing performance in robot-assisted surgery.&#xD;
&#xD;
      Design: Forty-one surgical residents will be randomly assigned to training and control&#xD;
      conditions. (1) participants will perform two da-Vinci skills simulator (dVSS) tasks to&#xD;
      determine baseline performance. (2) the training group will undergo computer-based simulator&#xD;
      training of spatial skills while the control group will engage in a neutral activity. (3) two&#xD;
      dVSS tasks will be performed within 2 days of training completion to evaluate post-training&#xD;
      performance. The experiment will be conducted until December 2018.&#xD;
&#xD;
      Participants: A convenience sample comprised of 41 surgical residents with non-robotic&#xD;
      surgical suturing skills.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">January 1, 2018</completion_date>
  <primary_completion_date type="Actual">September 1, 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>Tissue piercing</measure>
    <time_frame>up to 2 hours from enrollment</time_frame>
    <description>Number of times tissue was pierced during suturing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tissue tearing</measure>
    <time_frame>up to 2 hours from enrollment</time_frame>
    <description>Number of times tissue was teared during suturing</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Spatial Learning</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Surgical residents undergoing spatial skill training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Surgical residents not undergoing spatial skill training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Computerized spatial skill training</intervention_name>
    <description>The spatial skills training session consisted of six practice trials that were run in a sequence. The objective of each practice was to manipulate the simulated robotic arm to grab the cubes and move them to a desired location using keyboard keys. The participant was required to reach a decision based on the visual-spatial information, before initiating subsequent movements of the simulated robotic arm. Each practice trial presented an initial state of the cubes in front of the robotic arm, and a target position of the cubes.</description>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Watching a presentation regarding robotic surgery</intervention_name>
    <description>Watching a 20-35 minute long power-point presentation regarding the history of robotic surgery.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Surgical Residents with no previous robotic surgery experience.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non surgical residents.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roy Lauterbach, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rambam Health Care Campus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rambam health care campus</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 24, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>November 27, 2018</last_update_submitted>
  <last_update_submitted_qc>November 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rambam Health Care Campus</investigator_affiliation>
    <investigator_full_name>ROY LAUTERBACH MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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/NCT03758586
org study id: 0602-18-RMB
nct id: NCT03758586
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Surgical residents from a single tertiary medical center were divided into 2 groups. All
      residents performed 2 tasks on a Da Vinci robotic simulator system after which they were
      either given a real training session in spatial skills (study group) or shown a short
      presentation regarding robotic surgery. After training/watching the presentation, they
      repeated the for mentioned tasks on the robotic simulator. Improvement in surgeon
      performance, especially regarding tissue damage was documented.
Importance: Robot-assisted surgery is becoming the mainstay of modern surgery. Efficient
      training techniques are essential for enhanced performance. Optimal performance during a
      surgical task is key to successful surgery and minimal adverse events.

      Objective: To introduce and examine a single session of spatial skill training as an
      efficient means of improving surgical suturing performance in robot-assisted surgery.

      Design: Forty-one surgical residents will be randomly assigned to training and control
      conditions. (1) participants will perform two da-Vinci skills simulator (dVSS) tasks to
      determine baseline performance. (2) the training group will undergo computer-based simulator
      training of spatial skills while the control group will engage in a neutral activity. (3) two
      dVSS tasks will be performed within 2 days of training completion to evaluate post-training
      performance. The experiment will be conducted until December 2018.

      Participants: A convenience sample comprised of 41 surgical residents with non-robotic
      surgical suturing skills.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Tissue piercing
time frame: up to 2 hours from enrollment
description: Number of times tissue was pierced during suturing
measure: Tissue tearing
time frame: up to 2 hours from enrollment
description: Number of times tissue was teared during suturing
arm group label: Study group
arm group type: Active Comparator
description: Surgical residents undergoing spatial skill training.
arm group label: Control group
arm group type: Sham Comparator
description: Surgical residents not undergoing spatial skill training.
intervention type: Other
intervention name: Computerized spatial skill training
description: The spatial skills training session consisted of six practice trials that were run in a sequence. The objective of each practice was to manipulate the simulated robotic arm to grab the cubes and move them to a desired location using keyboard keys. The participant was required to reach a decision based on the visual-spatial information, before initiating subsequent movements of the simulated robotic arm. Each practice trial presented an initial state of the cubes in front of the robotic arm, and a target position of the cubes.
arm group label: Study group
intervention type: Other
intervention name: Watching a presentation regarding robotic surgery
description: Watching a 20-35 minute long power-point presentation regarding the history of robotic surgery.
arm group label: Control group
criteria: 
gender: All
minimum age: 25 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Roy Lauterbach, MD
role: Principal Investigator
affiliation: Rambam Health Care Campus
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Rambam Health Care Campus
investigator full name: ROY LAUTERBACH MD
investigator title: Principal Investigator
sharing ipd: No