<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/NCT03765320</url>
  </required_header>
  <id_info>
    <org_study_id>107150-E</org_study_id>
    <nct_id>NCT03765320</nct_id>
  </id_info>
  <brief_title>Impact of Peritoneal Closure and Retroperitoneal Drainage on Patients Who Underwent Laparotomic Retroperitoneal Lymph Node Dissection</brief_title>
  <official_title>Impact of Peritoneal Closure and Retroperitoneal Drainage on Patients Who Underwent Laparotomic Retroperitoneal Lymph Node Dissection for Early Gynecological Cancer</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 elucidate whether peritoneal closure and retroperitoneal drainage can benefit clinical&#xD;
      outcome of early gynecologic cancer patients who underwent retroperitoneal lymph node&#xD;
      dissection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To elucidate whether peritoneal closure and retroperitoneal drainage can benefit clinical&#xD;
      outcome of early gynecologic cancer patients who underwent retroperitoneal lymph node&#xD;
      dissection by reviewing the medical records of patients who underwent retroperitoneal lymph&#xD;
      node dissection for stage I or II gynecological cancer in Far Eastern Memorial Hospital,&#xD;
      January 2011~December 2017.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 6, 2018</start_date>
  <completion_date type="Actual">March 25, 2019</completion_date>
  <primary_completion_date type="Actual">February 12, 2019</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>Factors predicting lymphocele occurrence</measure>
    <time_frame>10 year</time_frame>
    <description>To find independent factors that can predict lymphocele occurrence in patients who underwent laparotomic gynecologic oncologic surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Factors predicting surgical complication</measure>
    <time_frame>10 years</time_frame>
    <description>To find independent factors that can predict occurrence of surgical complication in patients who underwent laparotomic gynecologic oncologic surgery</description>
  </secondary_outcome>
  <enrollment type="Actual">204</enrollment>
  <condition>Lymphocele</condition>
  <condition>Gynecologic Cancer</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Peritoneal closure</intervention_name>
    <description>Peritoneal closure after pelvic lymph node dissection for early gynecologic cancer</description>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Retroperitoneal drainage</intervention_name>
    <description>Retroperitoneal drainage after pelvic lymph node dissection for early gynecologic cancer</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Early gynecologic cancer patients who underwent retroperitoneal lymph node dissection in&#xD;
        Far Eastern Memorial Hospital between January 2011 and December 2017.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stage I or stage II gynecologic cancer (including cervical cancer, endometrial cancer,&#xD;
             ovarian cancer, and fallopian tube cancer)&#xD;
&#xD;
          -  Underwent laparotomic gynecologic oncologic surgery, including retroperitoneal&#xD;
             lymphadenectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  nil&#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>October 2019</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>October 19, 2019</last_update_submitted>
  <last_update_submitted_qc>October 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2019</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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphocele</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03765320
org study id: 107150-E
nct id: NCT03765320
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To elucidate whether peritoneal closure and retroperitoneal drainage can benefit clinical
      outcome of early gynecologic cancer patients who underwent retroperitoneal lymph node
      dissection.
To elucidate whether peritoneal closure and retroperitoneal drainage can benefit clinical
      outcome of early gynecologic cancer patients who underwent retroperitoneal lymph node
      dissection by reviewing the medical records of patients who underwent retroperitoneal lymph
      node dissection for stage I or II gynecological cancer in Far Eastern Memorial Hospital,
      January 2011~December 2017.
observational model: Cohort
time perspective: Retrospective
measure: Factors predicting lymphocele occurrence
time frame: 10 year
description: To find independent factors that can predict lymphocele occurrence in patients who underwent laparotomic gynecologic oncologic surgery
measure: Factors predicting surgical complication
time frame: 10 years
description: To find independent factors that can predict occurrence of surgical complication in patients who underwent laparotomic gynecologic oncologic surgery
intervention type: Procedure
intervention name: Peritoneal closure
description: Peritoneal closure after pelvic lymph node dissection for early gynecologic cancer
intervention type: Procedure
intervention name: Retroperitoneal drainage
description: Retroperitoneal drainage after pelvic lymph node dissection for early gynecologic cancer
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
mesh term: Lymphocele
sharing ipd: Undecided