<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/NCT03753516</url>
  </required_header>
  <id_info>
    <org_study_id>WRNMMC-2017-0055</org_study_id>
    <nct_id>NCT03753516</nct_id>
  </id_info>
  <brief_title>Pelvic Floor Support After Laparoscopic Hysterectomy for Benign Conditions: A Randomized Controlled Trial Comparing Vaginal Cuff Closure Techniques</brief_title>
  <official_title>Pelvic Floor Support After Laparoscopic Hysterectomy for Benign Conditions: A Randomized Controlled Trial Comparing Vaginal Cuff Closure Techniques</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Walter Reed National Military Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Walter Reed National Military Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study is to learn about the effect of different vaginal cuff closure&#xD;
      techniques on pelvic support after laparoscopic hysterectomy and robotic assisted&#xD;
      laparoscopic hysterectomy for benign gynecologic conditions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pelvic Organ Prolapse - Quantification Point C</measure>
    <time_frame>6-8 weeks post op</time_frame>
    <description>The Pelvic Organ Prolapse - Quantification system is a validated way to measure pelvic organ prolapse. The investigators will measure this post op at 6-8 weeks to see if prolapse is better using one method vs the other.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pelvic Organ Prolapse - Quantification Point C</measure>
    <time_frame>1 year post op</time_frame>
    <description>The Pelvic Organ Prolapse - Quantification system is a validated way to measure pelvic organ prolapse. The investigators will measure this post op at 1 year to see if prolapse is better using one method vs the other.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vaginal Cuff Dehiscence</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vaginal Cuff Abscess</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vaginal Cuff Cellulitis</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vaginal Cuff bleeding</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">78</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <arm_group>
    <arm_group_label>Laparoscopic - Vaginal Cuff Closure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Vaginal - Vaginal Cuff Closure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic - Vaginal Cuff Closure</intervention_name>
    <description>All participants are scheduled for either laparoscopic or robotic assisted total hysterectomy. At the end of the hysterectomy the vaginal cuff is closed. In this arm the vaginal cuff will be close laparoscopically using an 0-Barbed suture.</description>
    <arm_group_label>Laparoscopic - Vaginal Cuff Closure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Vaginal- Vaginal Cuff Closure</intervention_name>
    <description>All participants are scheduled for either laparoscopic or robotic assisted total hysterectomy. At the end of the hysterectomy the vaginal cuff is closed. In this arm the vaginal cuff will be close vaginally using an 0-Vicryl suture in a vertical fashion.</description>
    <arm_group_label>Vaginal - Vaginal Cuff Closure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women over 18 years of age undergoing total laparoscopic hysterectomy and robotic&#xD;
             assisted total laparoscopic hysterectomy for benign disease.&#xD;
&#xD;
          -  Subjects must be able to self-consent.&#xD;
&#xD;
          -  Department of Defense beneficiary&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients will be excluded if they undergo a concurrent procedure for prolapse.&#xD;
&#xD;
          -  If the indication for the procedure is a malignancy.&#xD;
&#xD;
          -  Those that plan to leave the area in less than 1 year will not be included.&#xD;
&#xD;
          -  Pop-Q Point C of &gt;-4&#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_contact>
    <last_name>Scott Endicott, MD</last_name>
    <phone>301-400-2140</phone>
    <email>scott.p.endicott.mil@mail.mil</email>
  </overall_contact>
  <location>
    <facility>
      <name>Walter Reed National Military Medical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20889</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Scott Endicott, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>May 26, 2020</last_update_submitted>
  <last_update_submitted_qc>May 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</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>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/NCT03753516
org study id: WRNMMC-2017-0055
nct id: NCT03753516
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to learn about the effect of different vaginal cuff closure
      techniques on pelvic support after laparoscopic hysterectomy and robotic assisted
      laparoscopic hysterectomy for benign gynecologic conditions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Pelvic Organ Prolapse - Quantification Point C
time frame: 6-8 weeks post op
description: The Pelvic Organ Prolapse - Quantification system is a validated way to measure pelvic organ prolapse. The investigators will measure this post op at 6-8 weeks to see if prolapse is better using one method vs the other.
measure: Pelvic Organ Prolapse - Quantification Point C
time frame: 1 year post op
description: The Pelvic Organ Prolapse - Quantification system is a validated way to measure pelvic organ prolapse. The investigators will measure this post op at 1 year to see if prolapse is better using one method vs the other.
measure: Vaginal Cuff Dehiscence
time frame: 1 year
measure: Vaginal Cuff Abscess
time frame: 1 year
measure: Vaginal Cuff Cellulitis
time frame: 1 year
measure: Vaginal Cuff bleeding
time frame: 1 year
arm group label: Laparoscopic - Vaginal Cuff Closure
arm group type: Active Comparator
arm group label: Vaginal - Vaginal Cuff Closure
arm group type: Active Comparator
intervention type: Procedure
intervention name: Laparoscopic - Vaginal Cuff Closure
description: All participants are scheduled for either laparoscopic or robotic assisted total hysterectomy. At the end of the hysterectomy the vaginal cuff is closed. In this arm the vaginal cuff will be close laparoscopically using an 0-Barbed suture.
arm group label: Laparoscopic - Vaginal Cuff Closure
intervention type: Procedure
intervention name: Vaginal- Vaginal Cuff Closure
description: All participants are scheduled for either laparoscopic or robotic assisted total hysterectomy. At the end of the hysterectomy the vaginal cuff is closed. In this arm the vaginal cuff will be close vaginally using an 0-Vicryl suture in a vertical fashion.
arm group label: Vaginal - Vaginal Cuff Closure
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Scott Endicott, MD
phone: 301-400-2140
email: scott.p.endicott.mil@mail.mil
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse
sharing ipd: No