<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/NCT01712607</url>
  </required_header>
  <id_info>
    <org_study_id>Warm-Up-1.0</org_study_id>
    <nct_id>NCT01712607</nct_id>
  </id_info>
  <brief_title>Preoperative Warm-up in Gynecologic Surgery</brief_title>
  <official_title>Preoperative Warm-up in Gynecologic Surgery Using a Virtual Reality Simulator.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background and Objectives: All modern surgical procedures require a high level of cognitive&#xD;
      and psychomotor skills achieved using different training methods, but could be influenced by&#xD;
      fatigue and other psychological factors. We evaluate the effect of warm-up exercises on&#xD;
      operative laparoscopic performances in gynecologic laparoscopic procedures.&#xD;
&#xD;
      Methods: The surgical team operates on a consecutive series of 20 patients and perform&#xD;
      laparoscopic salpingo-oophorectomy. Patients are randomly allocated in 2 groups: group A to&#xD;
      be operated on without warm-up exercises and group B to be operated on after a short-term&#xD;
      warm-up. All patients are operated on by the same surgical team. The full-time records of the&#xD;
      operation were analyzed by 2 independent reviewers. Laparoscopic procedures are recorded and&#xD;
      assessed by 2 independent observers using the generic OSATS rating scale. A training module&#xD;
      using the Lap Sim simulator was designed for the warm-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Surgical performance</measure>
    <time_frame>During surgery</time_frame>
    <description>Surgical Performance will be assessed using Objective structured assessment of technical skills (OSATS)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Gynecologic Disorders</condition>
  <arm_group>
    <arm_group_label>Warm-Up</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Surgery after warm-up task Preoperative Warm-Up training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Warm-up</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Surgery without warm-up exercise</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Preoperative Warm-Up training</intervention_name>
    <description>Preoperative Warm-Up training</description>
    <arm_group_label>Warm-Up</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  residents or faculty at the Dept. of Gynecology and Obstetrics&#xD;
&#xD;
          -  completed skills training&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephan Polterauer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Vienna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dept. Gynecology and Obstetrics, Medical University of Vienna, Austria</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <link>
    <url>http://www.meduniwien.ac.at/SSTC/</url>
    <description>Surgical Skills Training Center, Medical University of Vienna</description>
  </link>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>October 20, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>June 14, 2015</last_update_submitted>
  <last_update_submitted_qc>June 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Stephan Polterauer</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>laparoscopy</keyword>
  <keyword>surgery</keyword>
  <keyword>warm-up</keyword>
  <keyword>preoperative</keyword>
  <keyword>surgical skills</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Genital Diseases, Female</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>October 30, 2016</submitted>
    <returned>December 27, 2016</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/NCT01712607
org study id: Warm-Up-1.0
nct id: NCT01712607
lead sponsor: 
has dmc: No
Background and Objectives: All modern surgical procedures require a high level of cognitive
      and psychomotor skills achieved using different training methods, but could be influenced by
      fatigue and other psychological factors. We evaluate the effect of warm-up exercises on
      operative laparoscopic performances in gynecologic laparoscopic procedures.

      Methods: The surgical team operates on a consecutive series of 20 patients and perform
      laparoscopic salpingo-oophorectomy. Patients are randomly allocated in 2 groups: group A to
      be operated on without warm-up exercises and group B to be operated on after a short-term
      warm-up. All patients are operated on by the same surgical team. The full-time records of the
      operation were analyzed by 2 independent reviewers. Laparoscopic procedures are recorded and
      assessed by 2 independent observers using the generic OSATS rating scale. A training module
      using the Lap Sim simulator was designed for the warm-up.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Surgical performance
time frame: During surgery
description: Surgical Performance will be assessed using Objective structured assessment of technical skills (OSATS)
arm group label: Warm-Up
arm group type: Experimental
description: Surgery after warm-up task Preoperative Warm-Up training
arm group label: No Warm-up
arm group type: No Intervention
description: Surgery without warm-up exercise
intervention type: Other
intervention name: Preoperative Warm-Up training
description: Preoperative Warm-Up training
arm group label: Warm-Up
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stephan Polterauer
role: Principal Investigator
affiliation: Medical University of Vienna
facility: 
country: Austria
url: http://www.meduniwien.ac.at/SSTC/
description: Surgical Skills Training Center, Medical University of Vienna
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Stephan Polterauer
investigator title: MD
mesh term: Genital Diseases, Female
submitted: October 30, 2016
returned: December 27, 2016