xml: <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/NCT05969405</url>
    </required_header>
    <id_info>
      <org_study_id>112002-E</org_study_id>
      <nct_id>NCT05969405</nct_id>
    </id_info>
    <brief_title>Comparison of Prognosis in Endometrial Cancer Treated With Different Surgical Methods: Laparoscopy, Robotic-assisted Laparoscopy and Laparotomy</brief_title>
    <official_title>Comparison of Prognosis in Endometrial Cancer Treated With Different Surgical Methods: Laparoscopy, Robotic-assisted Laparoscopy and Laparotomy</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>
        Objective：To compare the clinical outcomes of endometrial cancer patients who received&#xD;
        surgerical treatments: Comparisons of robotic-assisted laparoscopic, laparoscopic and&#xD;
        laparotomic methods&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        We will review the medical records of clinically uterine-confined endometrial cancer women&#xD;
        who received robotic-assisted laparoscopic, laparoscopic or laparotomic methods; and compare&#xD;
        their outcomes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 7, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Overall survival</measure>
      <time_frame>5 years</time_frame>
      <description>Overall survival</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Progression free survival</measure>
      <time_frame>5 years</time_frame>
      <description>Progression free survival</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>length of hospital stay</measure>
      <time_frame>2 weeks</time_frame>
      <description>length of hospital stay</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>surgical time</measure>
      <time_frame>1 day</time_frame>
      <description>surgical time</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Estimate blood loss</measure>
      <time_frame>1 day</time_frame>
      <description>Estimate blood loss</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>lymph node number</measure>
      <time_frame>1 day</time_frame>
      <description>dissected lymph node number</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Endometrial Cancer</condition>
    <arm_group>
      <arm_group_label>Laparoscopy</arm_group_label>
      <description>Laparoscopic staging group</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Robotic</arm_group_label>
      <description>Robotic staing group</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Laparotomic</arm_group_label>
      <description>Laparotomic group</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Laparoscopic staging</intervention_name>
      <description>Laparoscopic staging</description>
      <arm_group_label>Laparoscopy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Robotic staging</intervention_name>
      <description>Robotic staging</description>
      <arm_group_label>Robotic</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Laparotomic staging</intervention_name>
      <description>Laparotomic staging</description>
      <arm_group_label>Laparotomic</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          endometrial cancer patients&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  womwn who received endometrial cancer surgical from January 01, 2008 to November 30,&#xD;
               2022 were be reviewed.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Endometrial cancer patients did not undergo surgery.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Women with endometrial cancer who were treated in Far Eastern Memorial Hospital from January 01, 2008 to November 30, 2022 were be reviewed.</gender_description>
      <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>
      <status>Recruiting</status>
      <contact>
        <last_name>Sheng-Mou Hsiao, M.D.</last_name>
        <phone>+886-2-89667000</phone>
        <phone_ext>1818</phone_ext>
        <email>smhsiao2@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</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>Endometrial Neoplasms</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05969405
  org study id: 112002-E
  nct id: NCT05969405
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Objective：To compare the clinical outcomes of endometrial cancer patients who received
        surgerical treatments: Comparisons of robotic-assisted laparoscopic, laparoscopic and
        laparotomic methods
  We will review the medical records of clinically uterine-confined endometrial cancer women
        who received robotic-assisted laparoscopic, laparoscopic or laparotomic methods; and compare
        their outcomes.
  observational model: Case-Control
  time perspective: Retrospective
  measure: Overall survival
  time frame: 5 years
  description: Overall survival
  measure: Progression free survival
  time frame: 5 years
  description: Progression free survival
  measure: length of hospital stay
  time frame: 2 weeks
  description: length of hospital stay
  measure: surgical time
  time frame: 1 day
  description: surgical time
  measure: Estimate blood loss
  time frame: 1 day
  description: Estimate blood loss
  measure: lymph node number
  time frame: 1 day
  description: dissected lymph node number
  arm group label: Laparoscopy
  description: Laparoscopic staging group
  arm group label: Robotic
  description: Robotic staing group
  arm group label: Laparotomic
  description: Laparotomic group
  intervention type: Procedure
  intervention name: Laparoscopic staging
  description: Laparoscopic staging
  arm group label: Laparoscopy
  intervention type: Procedure
  intervention name: Robotic staging
  description: Robotic staging
  arm group label: Robotic
  intervention type: Procedure
  intervention name: Laparotomic staging
  description: Laparotomic staging
  arm group label: Laparotomic
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Women with endometrial cancer who were treated in Far Eastern Memorial Hospital from January 01, 2008 to November 30, 2022 were be reviewed.
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  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: Endometrial Neoplasms