<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/NCT02192606</url>
  </required_header>
  <id_info>
    <org_study_id>3DRCT</org_study_id>
    <nct_id>NCT02192606</nct_id>
  </id_info>
  <brief_title>Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?</brief_title>
  <acronym>3DRCT</acronym>
  <official_title>Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? A Randomized Controlled Trial Comparing 3D Laparoscopy Versus Standard Laparoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective aim is to evaluate whether the use of 3D laparoscopy facilitates the vaginal&#xD;
      cuff closure of the vaginal cuff during a total laparoscopic hysterectomy among novice&#xD;
      laparoscopists (PGY 2-4, Fellow). This is a randomized single blinded controlled trial&#xD;
      comparing the difference in 2D vs. 3D in regards to vaginal cuff closure time stratified by&#xD;
      residents and fellows. Patients will undergo a total laparoscopic hysterectomy and will be&#xD;
      randomized to either 2D versus 3D.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized single blinded controlled trial investigating 3D laparoscopy in the&#xD;
      clinical setting. Based on previous studies indicating 3D laparoscopy has improved skills of&#xD;
      novice surgeons in the simulation lab, there has been no reports to date investigating the&#xD;
      role of 3D laparoscopy in the operating room. Our study will evaluate the facility of 3D&#xD;
      laparoscopy in the novice surgeon, mainly residents and fellow. Patients who present for a&#xD;
      scheduled total laparoscopic hysterectomy will be randomized to either the standard 2D&#xD;
      laparoscopy system or 3D laparoscopy system. Stratifying residents versus fellow, we will&#xD;
      compare the time to close the vaginal cuff comparing both systems.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2013</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Vaginal Cuff Closure Times</measure>
    <time_frame>Start of vaginal cuff closure to end of vaginal cuff closure</time_frame>
    <description>The primary endpoint is the vaginal cuff closure time at the time of a total laparoscopic hysterectomy. As the 2D laparoscopy system is standard during laparoscopic cases, our objective is to assess if there is a difference in vaginal cuff closure time when a 3D laparoscopy system is used instead. At time of the surgery, that patient will be randomized to either system. A resident or fellow will close the vaginal cuff and time to close the vaginal cuff will be recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Estimated Blood Loss at the Time of Total Laparoscopic Hysterectomy</measure>
    <time_frame>Time of Procedure End</time_frame>
    <description>The secondary endpoint is the surgeon estimated blood loss at the time of a total laparoscopic hysterectomy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Uterine Fibroids</condition>
  <condition>Abnormal Uterine Bleeding</condition>
  <condition>Pelvic Pain</condition>
  <condition>Adenomyosis</condition>
  <arm_group>
    <arm_group_label>2D Laparoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3D laparoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Storz 3D Laparoscopy System</intervention_name>
    <description>The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.</description>
    <arm_group_label>3D laparoscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>2D Laparoscopy</intervention_name>
    <description>The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.</description>
    <arm_group_label>2D Laparoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with benign conditions such as uterine fibroids, menorrhagia, adenomyosis,&#xD;
             pelvic pain, abnormal uterine bleeding&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jon Einarsson, MD, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sarah L Cohen, MD, MPH</last_name>
    <role>Study Director</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brigham &amp; Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Bhayani SB, Andriole GL. Three-Dimensional (3D) Vision: Does It Improve Laparoscopic Skills? An Assessment of a 3D Head-Mounted Visualization System. Rev Urol. 2005 Fall;7(4):211-4.</citation>
    <PMID>16985832</PMID>
  </reference>
  <reference>
    <citation>Tanagho YS, Andriole GL, Paradis AG, Madison KM, Sandhu GS, Varela JE, Benway BM. 2D versus 3D visualization: impact on laparoscopic proficiency using the fundamentals of laparoscopic surgery skill set. J Laparoendosc Adv Surg Tech A. 2012 Nov;22(9):865-70. doi: 10.1089/lap.2012.0220. Epub 2012 Oct 16.</citation>
    <PMID>23072406</PMID>
  </reference>
  <reference>
    <citation>Einarsson JI, Wang KC, Cohen SL, Sandberg EM, Vree FEM, Jonsdottir GM, Gobern J, Brown DN. A Randomized Controlled Trial of Barbed versus Traditional Suture for Vaginal Cuff Closure at Time of Total Laparoscopic Hysterectomy: Preliminary Results. Abstracts/ Journal of Minimally Invasive Gynecology. 19 (2012); S36-70.</citation>
  </reference>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 5, 2013</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <results_first_submitted>July 11, 2017</results_first_submitted>
  <results_first_submitted_qc>October 3, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">October 6, 2017</results_first_posted>
  <last_update_submitted>January 18, 2018</last_update_submitted>
  <last_update_submitted_qc>January 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Jon I. Einarsson</investigator_full_name>
    <investigator_title>Division Chair, Minimally Invasive Gynecology</investigator_title>
  </responsible_party>
  <keyword>Laparoscopy</keyword>
  <keyword>3D Visual System</keyword>
  <keyword>Total Hysterectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leiomyoma</mesh_term>
    <mesh_term>Uterine Hemorrhage</mesh_term>
    <mesh_term>Adenomyosis</mesh_term>
    <mesh_term>Pelvic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>2D Laparoscopy</title>
          <description>The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy&#xD;
2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.</description>
        </group>
        <group group_id="P2">
          <title>3D Laparoscopy</title>
          <description>The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.&#xD;
Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>surgery type was changed</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>3D equipment rep unable to join</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>2D Laparoscopy</title>
          <description>The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy&#xD;
2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.</description>
        </group>
        <group group_id="B2">
          <title>3D Laparoscopy</title>
          <description>The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.&#xD;
Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="29"/>
            <count group_id="B2" value="28"/>
            <count group_id="B3" value="57"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.5" spread="5.2"/>
                    <measurement group_id="B2" value="43.9" spread="8.2"/>
                    <measurement group_id="B3" value="42.7" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Denmark</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Vaginal Cuff Closure Times</title>
        <description>The primary endpoint is the vaginal cuff closure time at the time of a total laparoscopic hysterectomy. As the 2D laparoscopy system is standard during laparoscopic cases, our objective is to assess if there is a difference in vaginal cuff closure time when a 3D laparoscopy system is used instead. At time of the surgery, that patient will be randomized to either system. A resident or fellow will close the vaginal cuff and time to close the vaginal cuff will be recorded.</description>
        <time_frame>Start of vaginal cuff closure to end of vaginal cuff closure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2D Laparoscopy</title>
            <description>The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy&#xD;
2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.</description>
          </group>
          <group group_id="O2">
            <title>3D Laparoscopy</title>
            <description>The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.&#xD;
Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.</description>
          </group>
        </group_list>
        <measure>
          <title>Vaginal Cuff Closure Times</title>
          <description>The primary endpoint is the vaginal cuff closure time at the time of a total laparoscopic hysterectomy. As the 2D laparoscopy system is standard during laparoscopic cases, our objective is to assess if there is a difference in vaginal cuff closure time when a 3D laparoscopy system is used instead. At time of the surgery, that patient will be randomized to either system. A resident or fellow will close the vaginal cuff and time to close the vaginal cuff will be recorded.</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.17" spread="5.98"/>
                    <measurement group_id="O2" value="12.54" spread="6.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Estimated Blood Loss at the Time of Total Laparoscopic Hysterectomy</title>
        <description>The secondary endpoint is the surgeon estimated blood loss at the time of a total laparoscopic hysterectomy.</description>
        <time_frame>Time of Procedure End</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2D Laparoscopy</title>
            <description>The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy&#xD;
2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.</description>
          </group>
          <group group_id="O2">
            <title>3D Laparoscopy</title>
            <description>The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.&#xD;
Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.</description>
          </group>
        </group_list>
        <measure>
          <title>Estimated Blood Loss at the Time of Total Laparoscopic Hysterectomy</title>
          <description>The secondary endpoint is the surgeon estimated blood loss at the time of a total laparoscopic hysterectomy.</description>
          <units>millileters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.74" spread="39.36"/>
                    <measurement group_id="O2" value="60.83" spread="62.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected from the day of surgery to 8 weeks following the operation.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>2D Laparoscopy</title>
          <description>The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy&#xD;
2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.</description>
        </group>
        <group group_id="E2">
          <title>3D Laparoscopy</title>
          <description>The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.&#xD;
Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary retention</sub_title>
                <description>Subject had postoperative urinary retention with transient Foley catheter needed but returned to normal by post-operative follow up.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Incision cellulitis</sub_title>
                <description>Subject was treated with antibiotics for postoperative incision cellulitis.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Yeast infection</sub_title>
                <description>Subjected was treated with diflucan for postoperative yeast infection.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Intraoperative complication</sub_title>
                <description>Intraoperative cystotomy (bladder injury), repaired laparoscopically. Normal recovery.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ER visit</sub_title>
                <description>Subject presented to ER 5 days after discharge concerned about blood clot in hand where IV had been. Seen and prescribed warm compresses and discharged.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Iritation around abdominal surgical incision site</sub_title>
                <description>Subject experienced some postoperative red/itching around incision sites - near smaller incisions like a rash; advised oral antihistamines and topical hydrocortisone for presumed dermabond reaction. Improved with treatment.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Reoperation for vaginal cuff dehiscence</sub_title>
                <description>Subject presented to ER 18 days after surgery with abdominal pain. Rxed with dilaudid; required re-operation for cuff dehiscence.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jon I. Einarsson</name_or_title>
      <organization>Brigham and Women's Hospital</organization>
      <phone>617-732-5500</phone>
      <email>jeinarsson@partners.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02192606
org study id: 3DRCT
nct id: NCT02192606
lead sponsor: 
has dmc: No
The objective aim is to evaluate whether the use of 3D laparoscopy facilitates the vaginal
      cuff closure of the vaginal cuff during a total laparoscopic hysterectomy among novice
      laparoscopists (PGY 2-4, Fellow). This is a randomized single blinded controlled trial
      comparing the difference in 2D vs. 3D in regards to vaginal cuff closure time stratified by
      residents and fellows. Patients will undergo a total laparoscopic hysterectomy and will be
      randomized to either 2D versus 3D.
This is a randomized single blinded controlled trial investigating 3D laparoscopy in the
      clinical setting. Based on previous studies indicating 3D laparoscopy has improved skills of
      novice surgeons in the simulation lab, there has been no reports to date investigating the
      role of 3D laparoscopy in the operating room. Our study will evaluate the facility of 3D
      laparoscopy in the novice surgeon, mainly residents and fellow. Patients who present for a
      scheduled total laparoscopic hysterectomy will be randomized to either the standard 2D
      laparoscopy system or 3D laparoscopy system. Stratifying residents versus fellow, we will
      compare the time to close the vaginal cuff comparing both systems.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Vaginal Cuff Closure Times
time frame: Start of vaginal cuff closure to end of vaginal cuff closure
description: The primary endpoint is the vaginal cuff closure time at the time of a total laparoscopic hysterectomy. As the 2D laparoscopy system is standard during laparoscopic cases, our objective is to assess if there is a difference in vaginal cuff closure time when a 3D laparoscopy system is used instead. At time of the surgery, that patient will be randomized to either system. A resident or fellow will close the vaginal cuff and time to close the vaginal cuff will be recorded.
measure: Estimated Blood Loss at the Time of Total Laparoscopic Hysterectomy
time frame: Time of Procedure End
description: The secondary endpoint is the surgeon estimated blood loss at the time of a total laparoscopic hysterectomy.
arm group label: 2D Laparoscopy
arm group type: Active Comparator
description: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy
arm group label: 3D laparoscopy
arm group type: Active Comparator
description: The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.
intervention type: Device
intervention name: Storz 3D Laparoscopy System
description: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.
arm group label: 3D laparoscopy
intervention type: Device
intervention name: 2D Laparoscopy
description: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.
arm group label: 2D Laparoscopy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jon Einarsson, MD, PhD, MPH
role: Principal Investigator
affiliation: Brigham and Women's Hospital
last name: Sarah L Cohen, MD, MPH
role: Study Director
affiliation: Brigham and Women's Hospital
facility: 
facility: 
country: Denmark
country: United States
citation: Bhayani SB, Andriole GL. Three-Dimensional (3D) Vision: Does It Improve Laparoscopic Skills? An Assessment of a 3D Head-Mounted Visualization System. Rev Urol. 2005 Fall;7(4):211-4.
PMID: 16985832
citation: Tanagho YS, Andriole GL, Paradis AG, Madison KM, Sandhu GS, Varela JE, Benway BM. 2D versus 3D visualization: impact on laparoscopic proficiency using the fundamentals of laparoscopic surgery skill set. J Laparoendosc Adv Surg Tech A. 2012 Nov;22(9):865-70. doi: 10.1089/lap.2012.0220. Epub 2012 Oct 16.
PMID: 23072406
citation: Einarsson JI, Wang KC, Cohen SL, Sandberg EM, Vree FEM, Jonsdottir GM, Gobern J, Brown DN. A Randomized Controlled Trial of Barbed versus Traditional Suture for Vaginal Cuff Closure at Time of Total Laparoscopic Hysterectomy: Preliminary Results. Abstracts/ Journal of Minimally Invasive Gynecology. 19 (2012); S36-70.
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Jon I. Einarsson
investigator title: Division Chair, Minimally Invasive Gynecology
mesh term: Leiomyoma
mesh term: Uterine Hemorrhage
mesh term: Adenomyosis
mesh term: Pelvic Pain
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 