<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/NCT03832543</url>
  </required_header>
  <id_info>
    <org_study_id>0651603</org_study_id>
    <nct_id>NCT03832543</nct_id>
  </id_info>
  <brief_title>Modified Uterosacral Ligament Suspension in Vaginal Hysterectomy</brief_title>
  <official_title>Modified Extraperitoneal Uterosacral Ligament Suspension in Preventing Cuff Prolapse Risk After Vaginal Hysterectomy; 4 Clamp Method</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kanuni Sultan Suleyman Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kanuni Sultan Suleyman Training and Research Hospital</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>
      Introduction : The extraperitoneal uterosacral ligament suspension (ULS) can be performed&#xD;
      during the removal of the uterus in vaginal hysterectomy to prevent cuff prolapse. In this&#xD;
      study, the modified extraperitoneal ULS technique was evaluated in terms of preventing cuff&#xD;
      prolapse.&#xD;
&#xD;
      Methods / Technique : Forty patients with second and third-stage uterine prolapse who were&#xD;
      operated were included in the study. During routine vaginal hysterectomy procedure performed&#xD;
      on patients, after sacrouterine ligaments which are the first-bites and uteroovarian and&#xD;
      round ligaments which are the last-bites have been sutured and knotted, these ligaments were&#xD;
      marked with 4-distinct clemps to make the right and left, upper and lower separation. After&#xD;
      vaginal cuff was closed the sutures hanged by the clamps were ligated together, and the cuff&#xD;
      tissue was stretched to the apical line.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2016</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">May 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative vaginal cuff prolapse</measure>
    <time_frame>2 years</time_frame>
    <description>During two years follow up after sugery if there is vaginal cuff prolapse or not. The measurement of the vaginal cuff distance to the hymenal ring with a calculator. The units were centimeter</description>
  </primary_outcome>
  <enrollment type="Actual">40</enrollment>
  <condition>Modified Extraperitoneal Uterosacral Ligament Suspension</condition>
  <condition>Vault Prolapse, Vaginal</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Stage 2 or 3 uterin prolapse who need surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stage 2 or 3 uterin prolapse&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contrandication for surgery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>40-75 years old</gender_description>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 2, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>February 6, 2019</last_update_submitted>
  <last_update_submitted_qc>February 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kanuni Sultan Suleyman Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Kerem Doga Seckin</investigator_full_name>
    <investigator_title>Ass. Prof Kerem Doga Seckin</investigator_title>
  </responsible_party>
  <keyword>Vaginal Hysterectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Prolapse</mesh_term>
    <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/NCT03832543
org study id: 0651603
nct id: NCT03832543
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Introduction : The extraperitoneal uterosacral ligament suspension (ULS) can be performed
      during the removal of the uterus in vaginal hysterectomy to prevent cuff prolapse. In this
      study, the modified extraperitoneal ULS technique was evaluated in terms of preventing cuff
      prolapse.

      Methods / Technique : Forty patients with second and third-stage uterine prolapse who were
      operated were included in the study. During routine vaginal hysterectomy procedure performed
      on patients, after sacrouterine ligaments which are the first-bites and uteroovarian and
      round ligaments which are the last-bites have been sutured and knotted, these ligaments were
      marked with 4-distinct clemps to make the right and left, upper and lower separation. After
      vaginal cuff was closed the sutures hanged by the clamps were ligated together, and the cuff
      tissue was stretched to the apical line.
observational model: Case-Only
time perspective: Prospective
measure: postoperative vaginal cuff prolapse
time frame: 2 years
description: During two years follow up after sugery if there is vaginal cuff prolapse or not. The measurement of the vaginal cuff distance to the hymenal ring with a calculator. The units were centimeter
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: 40-75 years old
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Kanuni Sultan Suleyman Training and Research Hospital
investigator full name: Kerem Doga Seckin
investigator title: Ass. Prof Kerem Doga Seckin
mesh term: Uterine Prolapse
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse
sharing ipd: No