<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/NCT03034499</url>
  </required_header>
  <id_info>
    <org_study_id>0631-16-RMB</org_study_id>
    <nct_id>NCT03034499</nct_id>
  </id_info>
  <brief_title>Single Versus Multi-port Robotic Assisted Sacrocolpopexy for Repair of Vaginal Apex Prolapse</brief_title>
  <official_title>Single Versus Multi-port Robotic Assisted Sacrocolpopexy for Repair of Vaginal Apex Prolapse</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rambam Health Care Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rambam Health Care Campus</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>
      A prospective randomized controlled study intended to compare the efficacy of 2 methods of&#xD;
      robotic assisted sacrocolpopexy for the repair of vaginal apex prolapse:&#xD;
&#xD;
        1. Via single-port.&#xD;
&#xD;
        2. Via multi-port.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One hundred female patients diagnosed with vaginal apex prolapse will be recruited to a&#xD;
      prospective randomized controlled study intended to compare the efficacy of 2 methods of&#xD;
      robotic assisted sacrocolpopexy:&#xD;
&#xD;
        1. Via single-port.&#xD;
&#xD;
        2. Via multi-port. The patients will be evaluated and randomized 2 weeks before the&#xD;
           expected date of surgery during which eligibility will be examined.&#xD;
&#xD;
      Patients' electronic files will be reviewed post operatively to acquire information regarding&#xD;
      medical history, prolapse scores, surgical information, anesthesia information and surgical&#xD;
      complications.&#xD;
&#xD;
      Patients will have 3 week and 3 month post operative follow-up sessions to determine surgical&#xD;
      success, late complications and patient satisfaction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2017</start_date>
  <completion_date type="Actual">April 1, 2019</completion_date>
  <primary_completion_date type="Actual">November 1, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of surgical time</measure>
    <time_frame>Up to four months (2 weeks before surgery until 3 months post-surgery).</time_frame>
    <description>Comparison of surgical time in single versus multi-port robotic assisted sacrocolpopexy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of surgical success</measure>
    <time_frame>Up to four months (2 weeks before surgery until 3 months post-surgery).</time_frame>
    <description>Comparison of surgical success in single versus multi-port robotic assisted sacrocolpopexy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of surgical complications</measure>
    <time_frame>Up to four months (2 weeks before surgery until 3 months post-surgery).</time_frame>
    <description>Comparison of surgical complications (including bleeding and post operative pain) in single versus multi-port robotic assisted sacrocolpopexy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <arm_group>
    <arm_group_label>Single-port sacrocolpopexy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with vaginal apex prolapse randomized to undergo repair by single-port sacrocolpopexy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multi-port sacrocolpopexy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with vaginal apex prolapse randomized to undergo repair by multi- port sacrocolpopexy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Single-port sacrocolpopexy</intervention_name>
    <description>Single-port sacrocolpopexy surgery for the repair of vaginal apex prolapse.</description>
    <arm_group_label>Single-port sacrocolpopexy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Multi-port sacrocolpopexy</intervention_name>
    <description>Multi-port sacrocolpopexy surgery for the repair of vaginal apex prolapse.</description>
    <arm_group_label>Multi-port sacrocolpopexy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients with vaginal apex prolapse that are eligible for repair by&#xD;
             sacrocolpopexy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients after previous hysterectomy.&#xD;
&#xD;
          -  Patients after previous surgical procedures for prolapse repair.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female patients.</gender_description>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roy Lauterbach, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rambam Health Care Campus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rambam health care campus</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>June 9, 2019</last_update_submitted>
  <last_update_submitted_qc>June 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rambam Health Care Campus</investigator_affiliation>
    <investigator_full_name>ROY LAUTERBACH MD</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</mesh_term>
  </condition_browse>
  <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/NCT03034499
org study id: 0631-16-RMB
nct id: NCT03034499
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A prospective randomized controlled study intended to compare the efficacy of 2 methods of
      robotic assisted sacrocolpopexy for the repair of vaginal apex prolapse:

        1. Via single-port.

        2. Via multi-port.
One hundred female patients diagnosed with vaginal apex prolapse will be recruited to a
      prospective randomized controlled study intended to compare the efficacy of 2 methods of
      robotic assisted sacrocolpopexy:

        1. Via single-port.

        2. Via multi-port. The patients will be evaluated and randomized 2 weeks before the
           expected date of surgery during which eligibility will be examined.

      Patients' electronic files will be reviewed post operatively to acquire information regarding
      medical history, prolapse scores, surgical information, anesthesia information and surgical
      complications.

      Patients will have 3 week and 3 month post operative follow-up sessions to determine surgical
      success, late complications and patient satisfaction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Comparison of surgical time
time frame: Up to four months (2 weeks before surgery until 3 months post-surgery).
description: Comparison of surgical time in single versus multi-port robotic assisted sacrocolpopexy.
measure: Comparison of surgical success
time frame: Up to four months (2 weeks before surgery until 3 months post-surgery).
description: Comparison of surgical success in single versus multi-port robotic assisted sacrocolpopexy.
measure: Comparison of surgical complications
time frame: Up to four months (2 weeks before surgery until 3 months post-surgery).
description: Comparison of surgical complications (including bleeding and post operative pain) in single versus multi-port robotic assisted sacrocolpopexy.
arm group label: Single-port sacrocolpopexy
arm group type: Active Comparator
description: Patients with vaginal apex prolapse randomized to undergo repair by single-port sacrocolpopexy.
arm group label: Multi-port sacrocolpopexy
arm group type: Active Comparator
description: Patients with vaginal apex prolapse randomized to undergo repair by multi- port sacrocolpopexy.
intervention type: Procedure
intervention name: Single-port sacrocolpopexy
description: Single-port sacrocolpopexy surgery for the repair of vaginal apex prolapse.
arm group label: Single-port sacrocolpopexy
intervention type: Procedure
intervention name: Multi-port sacrocolpopexy
description: Multi-port sacrocolpopexy surgery for the repair of vaginal apex prolapse.
arm group label: Multi-port sacrocolpopexy
criteria: 
gender: Female
gender based: Yes
gender description: Female patients.
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: Roy Lauterbach, MD
role: Principal Investigator
affiliation: Rambam Health Care Campus
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Rambam Health Care Campus
investigator full name: ROY LAUTERBACH MD
investigator title: Principal investigator
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse
sharing ipd: No