<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/NCT04414670</url>
  </required_header>
  <id_info>
    <org_study_id>109002-E</org_study_id>
    <nct_id>NCT04414670</nct_id>
  </id_info>
  <brief_title>Clinical Outcome of Laparoscopic or Robotic Metroplasty for Uterine Isthmocele</brief_title>
  <official_title>Clinical Outcome of Laparoscopic or Robotic Metroplasty for Uterine Isthmocele</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Far Eastern Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Far Eastern Memorial Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the clinical outcomes of conventional or robotic - laparoscopic metroplasty for&#xD;
      uterine isthmocele with the aid of a bending probe.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 17, 2020</start_date>
  <completion_date type="Actual">November 29, 2021</completion_date>
  <primary_completion_date type="Actual">September 8, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change of prolonged menstrual bleeding condition</measure>
    <time_frame>10 years</time_frame>
    <description>Symptoms improvement and perioperative complications</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of scar defect size</measure>
    <time_frame>10 years</time_frame>
    <description>Symptoms improvement and perioperative complications</description>
  </secondary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Laparoscopic or Robotic Metroplasty</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>C/S</intervention_name>
    <description>laparoscopic or robotic metroplasty</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        uterine isthmocele status post laparoscopic or robotic metroplasty&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt; 20 years of women&#xD;
&#xD;
          -  uterine isthmocele status post laparoscopic or robotic metroplasty with a bent uterine&#xD;
             sound&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those underwent traditional open surgery.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital</name>
      <address>
        <city>Banqiao</city>
        <state>New Taipei</state>
        <zip>22050</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>August 14, 2022</last_update_submitted>
  <last_update_submitted_qc>August 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Far Eastern Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Sheng-Mou Hsiao</investigator_full_name>
    <investigator_title>Chief, Department of Obstetrics &amp; Gynecology</investigator_title>
  </responsible_party>
  <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/NCT04414670
org study id: 109002-E
nct id: NCT04414670
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To evaluate the clinical outcomes of conventional or robotic - laparoscopic metroplasty for
      uterine isthmocele with the aid of a bending probe.
observational model: Cohort
time perspective: Retrospective
measure: Change of prolonged menstrual bleeding condition
time frame: 10 years
description: Symptoms improvement and perioperative complications
measure: Change of scar defect size
time frame: 10 years
description: Symptoms improvement and perioperative complications
intervention type: Procedure
intervention name: C/S
description: laparoscopic or robotic metroplasty
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Far Eastern Memorial Hospital
investigator full name: Sheng-Mou Hsiao
investigator title: Chief, Department of Obstetrics & Gynecology
sharing ipd: No