<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/NCT02234856</url>
  </required_header>
  <id_info>
    <org_study_id>30509</org_study_id>
    <nct_id>NCT02234856</nct_id>
  </id_info>
  <brief_title>Evaluation of Laparoscopic Hysterectomy Simulator</brief_title>
  <official_title>Evaluation of Laparoscopic Hysterectomy Simulator to Improve Cognitive Surgical Knowledge of Obstetrics and Gynecology Trainees</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Unity Health Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to test the validity of a new educational tool in the form of a computer&#xD;
      based video surgical simulator, that may be used to enhance the current teaching method of&#xD;
      how to perform a hysterectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ensuring the surgical competence of trainees is mandatory for all surgical residency&#xD;
      programs, yet most evaluations of graduating residents are based on observation and&#xD;
      subjective feedback. We have developed a computer based video surgical simulator to&#xD;
      facilitate cognitive knowledge of the step-by-step process needed to perform a laparoscopic&#xD;
      hysterectomy, learn essential pelvic anatomy and avoid surgical complications. Studies have&#xD;
      shown that when trainees already have the cognitive knowledge of how to perform a procedure,&#xD;
      they can focus more on learning surgical technique and how to minimize surgical&#xD;
      complications. Laparoscopy is becoming the standard of surgical care for gynecologic&#xD;
      patients. The benefits of minimally invasive surgery include reduced postoperative pain,&#xD;
      shorter hospitalization, less scarring, quicker return to normal activities, preservation of&#xD;
      immune response, and fewer long-term problems such as adhesions or incisional hernia. The&#xD;
      current challenge in surgical education is how to produce competent surgeons who are skilled&#xD;
      to perform and integrate the multiple advances in surgical technology. Surgical competency&#xD;
      involves proficiency in technical skills, decision-making (preoperative, operative, and&#xD;
      postoperative), and team performance all of which require knowledge and communication skills.&#xD;
      The increasing complexity of surgery and the requirements for mastery at laparotomy,&#xD;
      laparoscopy, and endoscopy reduces the feasibility of the traditional &quot;see one, do one, teach&#xD;
      one&quot; model of surgical education. Lack of training is considered a major barrier to&#xD;
      performing laparoscopic surgery. Alternative training modalities are required to acquire the&#xD;
      necessary surgical skills for laparoscopy. Although there is a transfer of skills and&#xD;
      knowledge to the trainee by the time of graduation, current training programs have not been&#xD;
      designed in a validated, effective, and competency-based manner. A successful laparoscopic&#xD;
      curriculum should incorporate a cognitive component in addition to the manual skills&#xD;
      component. Although the benefit of simulators as a method of surgical education has been&#xD;
      validated, comprehensive curriculum development is lacking. Most recently, Zevin et al.&#xD;
      (2012) conducted a Delphi consensus involving international experts in surgical education on&#xD;
      the principles for design, validation and implementation of a simulation-based surgical&#xD;
      training curriculum. The main components of the final framework included predevelopment&#xD;
      analysis; cognitive, psychomotor, and team-based training; curriculum validation, evaluation,&#xD;
      and improvement; and maintenance of training. They have produced a framework that is based on&#xD;
      the broad principles of educational theory that can be applied to any surgical specialty.&#xD;
      Several authors have emphasized the importance of cognitive teaching in a comprehensive&#xD;
      surgical skills training curriculum. Learning begins with the acquisition of&#xD;
      procedure-specific knowledge. Categories include pre-procedure assessment and preparation;&#xD;
      anatomic knowledge; safety and limitations of specific instruments; ergonomics; and&#xD;
      post-procedure management. A cognitive curriculum can include reading materials in the form&#xD;
      of text books or journal articles as well as procedural video tutorials. The cognitive&#xD;
      component should be studied by the trainee before technical skills training and should be&#xD;
      followed by satisfactory performance on a paper-based test of knowledge or a mock operative&#xD;
      note dictation. Teaching about errors commonly associated with the procedure should be&#xD;
      included so that trainees can anticipate or avoid them in the future, and recognize and&#xD;
      manage them if they occur. The purpose of this research study is to test the validity of a&#xD;
      new educational tool as an enhancement to the current teaching method of how to perform a&#xD;
      hysterectomy. Should our data substantiate our hypothesis, that cognitive function of&#xD;
      surgical trainees will be enhanced by use of the trainer, then the tool will be able to be&#xD;
      utilized as a new, advanced, creative tool for teaching how to perform a hysterectomy. This&#xD;
      tool might then be able to be utilized to advance the teaching of many other surgical&#xD;
      procedures to residents in many different surgical programs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">July 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of residents using validation tool</measure>
    <time_frame>7-10 days</time_frame>
    <description>Phase I will consist of two on line tests that assess surgical and anatomic knowledge. The tests will be separated by 7-10 days. Evaluation will determine the validity of the tests as well as creating a &quot;knowledge curve.&quot; Analyzing resident and faculty performance with a one-way analysis of variance, with level of training as the independent variable, will assess construct validity. Post hoc contrasts are done with Student-Newman-Keuls test. We will also evaluate the validity of the exam by comparing the performance of novice surgeons with more advanced residents and experts. Internal consistency of the examination, which is a measure of the reliability of the test, will be calculated using Cronbach's alpha test. Results will be presented as percentages, means and standard deviations based on the number of questions that are answered correctly.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of experts using validation tool</measure>
    <time_frame>7-10 days</time_frame>
    <description>Phase I will consist of two on line tests that assess surgical and anatomic knowledge. The tests will be separated by 7-10 days. Evaluation will determine the validity of the tests as well as creating a &quot;knowledge curve.&quot; Analyzing resident and faculty performance with a one-way analysis of variance, with level of training as the independent variable, will assess construct validity. Post hoc contrasts are done with Student-Newman-Keuls test. We will also evaluate the validity of the exam by comparing the performance of novice surgeons with more advanced residents and experts. Internal consistency of the examination, which is a measure of the reliability of the test, will be calculated using Cronbach's alpha test. Results will be presented as percentages, means and standard deviations based on the number of questions that are answered correctly.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Evaluation of Laparoscopic Hysterectomy Simulator</condition>
  <arm_group>
    <arm_group_label>conventional residency training</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>no intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laparoscopic Hysterectomy trainer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: An educational video and web-based e-module will be created. The final product will be reviewed by the expert contributors. Once approved, these tools will be showcased to a voluntary focus group of Obstetrics and Gynecology residents at the University of Toronto. A quantitative assessment of effectiveness of this tool will be performed through the use of pre- and post-tests of knowledge. A qualitative needs assessment will also be performed using post-viewing surveys. If found to be effective, this educational tool will be incorporated in the University of Toronto Obstetrics and Gynecology residency curriculum.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic Hysterectomy trainer</intervention_name>
    <description>In order to increase comfort level amongst Gynecologists, we aim to identify verbal and non-verbal components of teaching TLH through interview and video recordings. Utilizing qualitative analysis of common themes, we will develop an educational video and web-based e-module to be used by Gynecology residents and surgeons. We will also use a combination of quantitative pre- and post-tests and qualitative surveys to assess the effectiveness of such a training tool. Ultimately, the project aims to create a robust tool that can be implemented in Gynecology residencies.</description>
    <arm_group_label>Laparoscopic Hysterectomy trainer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Faculty in the Department of Ob-Gyn&#xD;
&#xD;
          -  Experienced OBGYN surgeons&#xD;
&#xD;
          -  Residents in the Department of Ob-Gyn&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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>Dr. Satkunaratnam Abheha, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unity Health Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Southern California, Department of Obstetrics and Gynecology</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Los Angeles, Department of Obstetrics and Gynecology</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington, School of Medicine, Department of Obstetrics and Gynecology</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of British Columbia, Division of Obstetrics and Gynecology</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Toronto Faculty of Medicine</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5S 1A8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center, Utrecht, The Netherlands</name>
      <address>
        <city>Utrecht</city>
        <state>Heidelberglaan</state>
        <zip>3508 GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Netherlands</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>February 20, 2019</last_update_submitted>
  <last_update_submitted_qc>February 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hysterectomy</keyword>
  <keyword>Laparoscopy</keyword>
  <keyword>Surgical assessment</keyword>
  <keyword>Education</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/NCT02234856
org study id: 30509
nct id: NCT02234856
lead sponsor: 
collaborator: 
has dmc: No
This study aims to test the validity of a new educational tool in the form of a computer
      based video surgical simulator, that may be used to enhance the current teaching method of
      how to perform a hysterectomy.
Ensuring the surgical competence of trainees is mandatory for all surgical residency
      programs, yet most evaluations of graduating residents are based on observation and
      subjective feedback. We have developed a computer based video surgical simulator to
      facilitate cognitive knowledge of the step-by-step process needed to perform a laparoscopic
      hysterectomy, learn essential pelvic anatomy and avoid surgical complications. Studies have
      shown that when trainees already have the cognitive knowledge of how to perform a procedure,
      they can focus more on learning surgical technique and how to minimize surgical
      complications. Laparoscopy is becoming the standard of surgical care for gynecologic
      patients. The benefits of minimally invasive surgery include reduced postoperative pain,
      shorter hospitalization, less scarring, quicker return to normal activities, preservation of
      immune response, and fewer long-term problems such as adhesions or incisional hernia. The
      current challenge in surgical education is how to produce competent surgeons who are skilled
      to perform and integrate the multiple advances in surgical technology. Surgical competency
      involves proficiency in technical skills, decision-making (preoperative, operative, and
      postoperative), and team performance all of which require knowledge and communication skills.
      The increasing complexity of surgery and the requirements for mastery at laparotomy,
      laparoscopy, and endoscopy reduces the feasibility of the traditional "see one, do one, teach
      one" model of surgical education. Lack of training is considered a major barrier to
      performing laparoscopic surgery. Alternative training modalities are required to acquire the
      necessary surgical skills for laparoscopy. Although there is a transfer of skills and
      knowledge to the trainee by the time of graduation, current training programs have not been
      designed in a validated, effective, and competency-based manner. A successful laparoscopic
      curriculum should incorporate a cognitive component in addition to the manual skills
      component. Although the benefit of simulators as a method of surgical education has been
      validated, comprehensive curriculum development is lacking. Most recently, Zevin et al.
      (2012) conducted a Delphi consensus involving international experts in surgical education on
      the principles for design, validation and implementation of a simulation-based surgical
      training curriculum. The main components of the final framework included predevelopment
      analysis; cognitive, psychomotor, and team-based training; curriculum validation, evaluation,
      and improvement; and maintenance of training. They have produced a framework that is based on
      the broad principles of educational theory that can be applied to any surgical specialty.
      Several authors have emphasized the importance of cognitive teaching in a comprehensive
      surgical skills training curriculum. Learning begins with the acquisition of
      procedure-specific knowledge. Categories include pre-procedure assessment and preparation;
      anatomic knowledge; safety and limitations of specific instruments; ergonomics; and
      post-procedure management. A cognitive curriculum can include reading materials in the form
      of text books or journal articles as well as procedural video tutorials. The cognitive
      component should be studied by the trainee before technical skills training and should be
      followed by satisfactory performance on a paper-based test of knowledge or a mock operative
      note dictation. Teaching about errors commonly associated with the procedure should be
      included so that trainees can anticipate or avoid them in the future, and recognize and
      manage them if they occur. The purpose of this research study is to test the validity of a
      new educational tool as an enhancement to the current teaching method of how to perform a
      hysterectomy. Should our data substantiate our hypothesis, that cognitive function of
      surgical trainees will be enhanced by use of the trainer, then the tool will be able to be
      utilized as a new, advanced, creative tool for teaching how to perform a hysterectomy. This
      tool might then be able to be utilized to advance the teaching of many other surgical
      procedures to residents in many different surgical programs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of residents using validation tool
time frame: 7-10 days
description: Phase I will consist of two on line tests that assess surgical and anatomic knowledge. The tests will be separated by 7-10 days. Evaluation will determine the validity of the tests as well as creating a "knowledge curve." Analyzing resident and faculty performance with a one-way analysis of variance, with level of training as the independent variable, will assess construct validity. Post hoc contrasts are done with Student-Newman-Keuls test. We will also evaluate the validity of the exam by comparing the performance of novice surgeons with more advanced residents and experts. Internal consistency of the examination, which is a measure of the reliability of the test, will be calculated using Cronbach's alpha test. Results will be presented as percentages, means and standard deviations based on the number of questions that are answered correctly.
measure: Number of experts using validation tool
time frame: 7-10 days
description: Phase I will consist of two on line tests that assess surgical and anatomic knowledge. The tests will be separated by 7-10 days. Evaluation will determine the validity of the tests as well as creating a "knowledge curve." Analyzing resident and faculty performance with a one-way analysis of variance, with level of training as the independent variable, will assess construct validity. Post hoc contrasts are done with Student-Newman-Keuls test. We will also evaluate the validity of the exam by comparing the performance of novice surgeons with more advanced residents and experts. Internal consistency of the examination, which is a measure of the reliability of the test, will be calculated using Cronbach's alpha test. Results will be presented as percentages, means and standard deviations based on the number of questions that are answered correctly.
arm group label: conventional residency training
arm group type: No Intervention
description: no intervention
arm group label: Laparoscopic Hysterectomy trainer
arm group type: Experimental
description: Intervention: An educational video and web-based e-module will be created. The final product will be reviewed by the expert contributors. Once approved, these tools will be showcased to a voluntary focus group of Obstetrics and Gynecology residents at the University of Toronto. A quantitative assessment of effectiveness of this tool will be performed through the use of pre- and post-tests of knowledge. A qualitative needs assessment will also be performed using post-viewing surveys. If found to be effective, this educational tool will be incorporated in the University of Toronto Obstetrics and Gynecology residency curriculum.
intervention type: Procedure
intervention name: Laparoscopic Hysterectomy trainer
description: In order to increase comfort level amongst Gynecologists, we aim to identify verbal and non-verbal components of teaching TLH through interview and video recordings. Utilizing qualitative analysis of common themes, we will develop an educational video and web-based e-module to be used by Gynecology residents and surgeons. We will also use a combination of quantitative pre- and post-tests and qualitative surveys to assess the effectiveness of such a training tool. Ultimately, the project aims to create a robust tool that can be implemented in Gynecology residencies.
arm group label: Laparoscopic Hysterectomy trainer
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Dr. Satkunaratnam Abheha, MD
role: Principal Investigator
affiliation: Unity Health Toronto
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: Netherlands
country: United States
responsible party type: Sponsor
sharing ipd: Undecided