<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/NCT01679522</url>
  </required_header>
  <id_info>
    <org_study_id>LESS-E</org_study_id>
    <nct_id>NCT01679522</nct_id>
  </id_info>
  <brief_title>Feasibility Study of Laparoendoscopic Single Site Surgical Staging for Endometrial Cancer</brief_title>
  <acronym>LESS-E</acronym>
  <official_title>Prospective Randomized Comparison of Single-port and Four-port Laparoscopic Staging Operation for Endometrial Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asan Medical Center</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>
      To compare the feasibility, safety, and efficacy between single-port and four-port&#xD;
      laparoscopic surgical staging in patients with early stage endometrial cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2013</start_date>
  <completion_date type="Actual">June 2022</completion_date>
  <primary_completion_date type="Actual">September 2021</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>operating time</measure>
    <time_frame>1 day (Immediately after operation)</time_frame>
    <description>Total operation time and time required for each procedure are calculated and compared.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of lymph nodes retrieved</measure>
    <time_frame>1 week after surgery</time_frame>
    <description>The number of right pelvic lymph nodes and left pelvic lymph nodes were obtained and compared.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>within 1 week after surgery</time_frame>
    <description>The VAS pain score was obtained every 8 hours after surgery and compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative analgesics requirement</measure>
    <time_frame>within 1 week after surgery</time_frame>
    <description>If the VAS pain score is 3 or more or the patient desires, additional pain medication is administered. The frequency of the pain medication administered in this way is investigated and compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>transfusion requirement and amount</measure>
    <time_frame>within 1 week after surgery</time_frame>
    <description>Investigate and compare blood transfusion volume and frequency during and after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative complications</measure>
    <time_frame>within 1 month after surgery</time_frame>
    <description>Compare the frequency of fever, urinary retention, anemia, and nausea after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>recurrence free survival</measure>
    <time_frame>34 months after surgery</time_frame>
    <description>Compare RFS during the follow-up period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>34 months after surgery</time_frame>
    <description>Compare OS during the follow-up period.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">107</enrollment>
  <condition>Endometrial Cancer</condition>
  <arm_group>
    <arm_group_label>Single-port surgery group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single-port laparoscopic surgical staging including total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Four-port surgery group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Four-port laparoscopic surgical staging including total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>single-port laparoscopic surgical staging</intervention_name>
    <description>single-port laparoscopic surgical staging indluding total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection</description>
    <arm_group_label>Single-port surgery group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Four-port laparoscopic surgical staging</intervention_name>
    <description>Four-port laparoscopic surgical staging indluding total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection</description>
    <arm_group_label>Four-port surgery group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previously untreated, histologically confirmed endometrial cancer&#xD;
&#xD;
          -  Presumed FIGO stage 1&#xD;
&#xD;
          -  Endometrioid adenocarcinoma&#xD;
&#xD;
          -  patient who is planned to undergo surgical staging&#xD;
&#xD;
          -  adequate oran function&#xD;
&#xD;
               1. WBC &gt; 3000 cells/mcl&#xD;
&#xD;
               2. Platelets &gt; 100000/mcl&#xD;
&#xD;
               3. Creatinine &lt; 2.0 mg/dL&#xD;
&#xD;
               4. Bilirubin &lt; 1.5 * normal and SGOT or SGPT &lt; 3 * normal&#xD;
&#xD;
          -  American Society of Anesthesiologists Physical Status I-II&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status 0-2&#xD;
&#xD;
          -  Patients who have signed an approved Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled medical disease&#xD;
&#xD;
          -  Active infectious disease requiring antibiotics&#xD;
&#xD;
          -  Previous pelvic radiation therapy&#xD;
&#xD;
          -  Pregnant and lactating woman&#xD;
&#xD;
          -  Patient who requires additional surgical procedures which are not necessary for&#xD;
             surgical staging of endometrial cancer&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joo-Hyun Nam, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>September 3, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>November 28, 2022</last_update_submitted>
  <last_update_submitted_qc>November 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Joo-Hyun Nam</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>endometrial cancer</keyword>
  <keyword>laparoscopic surgical staging</keyword>
  <keyword>single-port</keyword>
  <keyword>four-port</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometrial Neoplasms</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/NCT01679522
org study id: LESS-E
nct id: NCT01679522
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To compare the feasibility, safety, and efficacy between single-port and four-port
      laparoscopic surgical staging in patients with early stage endometrial cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: operating time
time frame: 1 day (Immediately after operation)
description: Total operation time and time required for each procedure are calculated and compared.
measure: Number of lymph nodes retrieved
time frame: 1 week after surgery
description: The number of right pelvic lymph nodes and left pelvic lymph nodes were obtained and compared.
measure: Postoperative pain
time frame: within 1 week after surgery
description: The VAS pain score was obtained every 8 hours after surgery and compared.
measure: Postoperative analgesics requirement
time frame: within 1 week after surgery
description: If the VAS pain score is 3 or more or the patient desires, additional pain medication is administered. The frequency of the pain medication administered in this way is investigated and compared.
measure: transfusion requirement and amount
time frame: within 1 week after surgery
description: Investigate and compare blood transfusion volume and frequency during and after surgery.
measure: postoperative complications
time frame: within 1 month after surgery
description: Compare the frequency of fever, urinary retention, anemia, and nausea after surgery.
measure: recurrence free survival
time frame: 34 months after surgery
description: Compare RFS during the follow-up period.
measure: overall survival
time frame: 34 months after surgery
description: Compare OS during the follow-up period.
arm group label: Single-port surgery group
arm group type: Experimental
description: Single-port laparoscopic surgical staging including total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection
arm group label: Four-port surgery group
arm group type: Active Comparator
description: Four-port laparoscopic surgical staging including total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection
intervention type: Procedure
intervention name: single-port laparoscopic surgical staging
description: single-port laparoscopic surgical staging indluding total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection
arm group label: Single-port surgery group
intervention type: Procedure
intervention name: Four-port laparoscopic surgical staging
description: Four-port laparoscopic surgical staging indluding total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection
arm group label: Four-port surgery group
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Joo-Hyun Nam, M.D., Ph.D.
role: Principal Investigator
affiliation: Asan Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Asan Medical Center
investigator full name: Joo-Hyun Nam
investigator title: Professor
mesh term: Endometrial Neoplasms
sharing ipd: Undecided