<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/NCT03230552</url>
  </required_header>
  <id_info>
    <org_study_id>17-124</org_study_id>
    <nct_id>NCT03230552</nct_id>
  </id_info>
  <brief_title>Effect of Pre-operative Training Using Surgical Videos on Resident Performance of Unilateral Salpigo-oophrectomy</brief_title>
  <official_title>Effect of Pre-operative Training Using Surgical Videos on Resident Performance of Unilateral Salpigo-oophrectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Unity Health Toronto</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>
      There is a need for the development and validation of new teaching strategies and resources&#xD;
      for surgical training that can occur outside of the operating room. The use of surgical&#xD;
      videos is not novel however it has not been validated as an effective approach for&#xD;
      gynecologic surgical training. The goals of our study are to (1) develop an educational&#xD;
      surgical video for laparoscopic salpingo-oophrectomy (LSO) and (2) to evaluate and test the&#xD;
      effectiveness of this tool in preparing residents for performance in the operating room.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the rapidly changing face of surgical education and with a pressure to adopt&#xD;
      competency-based training and assessment nationwide, obstetrics and gynecology residency&#xD;
      programs will be forced to implement effective strategies to ensure that learners acquire the&#xD;
      skill set required to become competent gynecologists. However, very few instructional tools&#xD;
      have been validated in gynecologic surgery. The use of surgical videos as a teaching strategy&#xD;
      may be one piece to this puzzle. Surgical videos are becoming increasingly popular, however,&#xD;
      their value as an effective instructional technique has yet to be validated. Should surgical&#xD;
      videos prove to be of benefit in surgical training it would offer an alternate modality to&#xD;
      optimize operating room experiences and learning for gynecology residents.&#xD;
&#xD;
      Obstetrics and gynecology residents in years one and two of their training (junior&#xD;
      residents), will view a teaching video about LSO (intervention group) compared to not&#xD;
      watching a video (control group) to assess if our intervention results in better performance&#xD;
      in the operating room for this procedure as rated by an objective structured assessment of&#xD;
      technical skills tool (OSAT) (primary outcome). Secondary outcome measures will include a&#xD;
      self-administered questionnaire grading knowledge and confidence, and a 5-point Likert scale&#xD;
      grading resident satisfaction with the video.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">August 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2019</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>
    <intervention_model_description>Randomized control trial</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective Structure Assessment of Technical Skills Tool (OSAT)</measure>
    <time_frame>Intraoperative (Beginning of surgery to end of surgery)</time_frame>
    <description>Surgeries performed by the residents will be video recorded. Resident performance during surgery will be rated using the OSAT tool.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pre-operative knowledge survey</measure>
    <time_frame>baseline</time_frame>
    <description>Residents will complete a survey prior surgery which will measure their pre-operative knowledge of performing LSO procedure.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Surgical Videos</condition>
  <condition>Pre-operative Training</condition>
  <arm_group>
    <arm_group_label>Video group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Residents assigned to this group will watch an instructional surgical video prior to LSO surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No video group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Residents assigned to this group will not watch an instructional surgical video prior to LSO surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Instructional surgical video</intervention_name>
    <description>An instructional surgical video shown to residents before they perform LSO surgery.</description>
    <arm_group_label>Video group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Novice OBGYN residents who have performed &lt;10 LSO surgeries as the primary surgeon&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  OBGYN residents who have performed &gt; 10 LSO surgeries as the primary surgeon.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eliane Shore, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unity Health Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5C 2T2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>February 19, 2019</last_update_submitted>
  <last_update_submitted_qc>February 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03230552
org study id: 17-124
nct id: NCT03230552
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There is a need for the development and validation of new teaching strategies and resources
      for surgical training that can occur outside of the operating room. The use of surgical
      videos is not novel however it has not been validated as an effective approach for
      gynecologic surgical training. The goals of our study are to (1) develop an educational
      surgical video for laparoscopic salpingo-oophrectomy (LSO) and (2) to evaluate and test the
      effectiveness of this tool in preparing residents for performance in the operating room.
In the rapidly changing face of surgical education and with a pressure to adopt
      competency-based training and assessment nationwide, obstetrics and gynecology residency
      programs will be forced to implement effective strategies to ensure that learners acquire the
      skill set required to become competent gynecologists. However, very few instructional tools
      have been validated in gynecologic surgery. The use of surgical videos as a teaching strategy
      may be one piece to this puzzle. Surgical videos are becoming increasingly popular, however,
      their value as an effective instructional technique has yet to be validated. Should surgical
      videos prove to be of benefit in surgical training it would offer an alternate modality to
      optimize operating room experiences and learning for gynecology residents.

      Obstetrics and gynecology residents in years one and two of their training (junior
      residents), will view a teaching video about LSO (intervention group) compared to not
      watching a video (control group) to assess if our intervention results in better performance
      in the operating room for this procedure as rated by an objective structured assessment of
      technical skills tool (OSAT) (primary outcome). Secondary outcome measures will include a
      self-administered questionnaire grading knowledge and confidence, and a 5-point Likert scale
      grading resident satisfaction with the video.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized control trial
primary purpose: Other
masking: None (Open Label)
measure: Objective Structure Assessment of Technical Skills Tool (OSAT)
time frame: Intraoperative (Beginning of surgery to end of surgery)
description: Surgeries performed by the residents will be video recorded. Resident performance during surgery will be rated using the OSAT tool.
measure: Pre-operative knowledge survey
time frame: baseline
description: Residents will complete a survey prior surgery which will measure their pre-operative knowledge of performing LSO procedure.
arm group label: Video group
arm group type: Experimental
description: Residents assigned to this group will watch an instructional surgical video prior to LSO surgery.
arm group label: No video group
arm group type: No Intervention
description: Residents assigned to this group will not watch an instructional surgical video prior to LSO surgery.
intervention type: Other
intervention name: Instructional surgical video
description: An instructional surgical video shown to residents before they perform LSO surgery.
arm group label: Video group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Eliane Shore, MD
role: Principal Investigator
affiliation: Unity Health Toronto
facility: 
country: Canada
responsible party type: Sponsor
sharing ipd: No