<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/NCT02258230</url>
  </required_header>
  <id_info>
    <org_study_id>4859</org_study_id>
    <nct_id>NCT02258230</nct_id>
  </id_info>
  <brief_title>Laparoscopic Three-dimensional Versus Two-dimensional Sacral Colpopexy and Paravaginal Repair</brief_title>
  <official_title>Laparoscopic 3D Versus 2D Sacral Colpopexy and Paravaginal Repair for Pelvic Organ Prolapse: a Comparison of Operative Times and Complications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Olympus Corporation of the Americas</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>International Urogynecology Associates</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Olympus Corporation of the Americas</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Compare operative times and complications of sacral colpopexy and paravaginal repair between&#xD;
      two-dimensional and three-dimensional laparoscopic systems.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to compare operative times of laparoscopic sacral colpopexy&#xD;
      (LSC) for the treatment of symptomatic vaginal vault prolapse as well as paravaginal repair&#xD;
      (PVR) for symptomatic cystocele between two-dimensional and three-dimensional laparoscopic&#xD;
      systems. Additionally this study will evaluate postoperative complications from surgeries&#xD;
      performed using two-dimensional versus three-dimensional laparoscopic systems.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2014</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">March 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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Operative Times</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Operative times of laparoscopic sacral colpopexy and paravaginal repair procedures from the first part of dissection until closure of the peritoneum.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>Intraoperative up to 6 weeks post procedure</time_frame>
    <description>Intraoperative complications will be recorded. Post operative complications will be reported for the first 6 weeks after the procedure.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">194</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <condition>Cystocele</condition>
  <arm_group>
    <arm_group_label>2D mode LSC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2D mode of the 3D Laparoscopic Video System for the Laprascopic Sacral Colpopexy (LSC) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3D mode LSC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>3D mode of the 3D Laparoscopic Video System for the Laprascopic Sacral Colpopexy (LSC) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2D mode PVR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2D mode of the 3D Laparoscopic Video System for the Paravaginal Repair (PVR) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3D mode PVR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>3D mode of the 3D Laparoscopic Video System for the Paravaginal Repair (PVR) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>3D mode of the 3D Laparoscopic Video System</intervention_name>
    <description>Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.</description>
    <arm_group_label>3D mode LSC</arm_group_label>
    <arm_group_label>3D mode PVR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>2D mode of the 3D Laparoscopic Video System</intervention_name>
    <description>Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.</description>
    <arm_group_label>2D mode LSC</arm_group_label>
    <arm_group_label>2D mode PVR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Symptomatic vaginal vault prolapse (stage 2 or greater point C-1 pelvic organ prolapse&#xD;
             quantification [POP-Q] or grade 2 or greater Baden-Walker half way system) undergoing&#xD;
             laparoscopic sacral colpopexy&#xD;
&#xD;
        And/Or&#xD;
&#xD;
          -  Symptomatic cystocele (stage 2 or greater, point Aa or Ba &gt; -1 POP-Q or grade 2 or&#xD;
             greater Baden-Walker half way system) undergoing laparoscopic paravaginal repair&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 18 years&#xD;
&#xD;
          -  Inability to comprehend questionnaires&#xD;
&#xD;
          -  Inability to give informed consent or to return for review&#xD;
&#xD;
          -  Vaginal vault prolapse &lt; stage 2&#xD;
&#xD;
          -  Unable to undergo general anesthesia&#xD;
&#xD;
          -  More than 5 previous laparotomies&#xD;
&#xD;
          -  Prior sacral colpopexy or vaginal mesh prolapse procedure&#xD;
&#xD;
          -  Prior surgery involving the retropubic space&#xD;
&#xD;
          -  Vaginal length less than 6 cm&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert D Moore, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>International Urogynecology Associates</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beverly Hills Sunset Surgery Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northside Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.miklosandmoore.com/</url>
    <description>International Urogynecology Associates' website</description>
  </link>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>April 3, 2018</last_update_submitted>
  <last_update_submitted_qc>April 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystocele</mesh_term>
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>January 21, 2022</submitted>
    <returned>February 14, 2022</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/NCT02258230
org study id: 4859
nct id: NCT02258230
lead sponsor: 
collaborator: 
has dmc: No
Compare operative times and complications of sacral colpopexy and paravaginal repair between
      two-dimensional and three-dimensional laparoscopic systems.
The purpose of this study is to compare operative times of laparoscopic sacral colpopexy
      (LSC) for the treatment of symptomatic vaginal vault prolapse as well as paravaginal repair
      (PVR) for symptomatic cystocele between two-dimensional and three-dimensional laparoscopic
      systems. Additionally this study will evaluate postoperative complications from surgeries
      performed using two-dimensional versus three-dimensional laparoscopic systems.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Operative Times
time frame: Intraoperative
description: Operative times of laparoscopic sacral colpopexy and paravaginal repair procedures from the first part of dissection until closure of the peritoneum.
measure: Complications
time frame: Intraoperative up to 6 weeks post procedure
description: Intraoperative complications will be recorded. Post operative complications will be reported for the first 6 weeks after the procedure.
arm group label: 2D mode LSC
arm group type: Active Comparator
description: 2D mode of the 3D Laparoscopic Video System for the Laprascopic Sacral Colpopexy (LSC) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.
arm group label: 3D mode LSC
arm group type: Active Comparator
description: 3D mode of the 3D Laparoscopic Video System for the Laprascopic Sacral Colpopexy (LSC) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.
arm group label: 2D mode PVR
arm group type: Active Comparator
description: 2D mode of the 3D Laparoscopic Video System for the Paravaginal Repair (PVR) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.
arm group label: 3D mode PVR
arm group type: Active Comparator
description: 3D mode of the 3D Laparoscopic Video System for the Paravaginal Repair (PVR) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.
intervention type: Device
intervention name: 3D mode of the 3D Laparoscopic Video System
description: Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.
arm group label: 3D mode LSC
arm group label: 3D mode PVR
intervention type: Device
intervention name: 2D mode of the 3D Laparoscopic Video System
description: Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.
arm group label: 2D mode LSC
arm group label: 2D mode PVR
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert D Moore, DO
role: Principal Investigator
affiliation: International Urogynecology Associates
facility: 
facility: 
country: United States
url: http://www.miklosandmoore.com/
description: International Urogynecology Associates' website
responsible party type: Sponsor
mesh term: Cystocele
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse
submitted: January 21, 2022
returned: February 14, 2022