<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/NCT01679483</url>
  </required_header>
  <id_info>
    <org_study_id>FloSeal-LND</org_study_id>
    <nct_id>NCT01679483</nct_id>
  </id_info>
  <brief_title>Efficacy Study of FloSeal for Prevention of Lymphocele After Lymphadenectomy for Gynecologic Cancer</brief_title>
  <official_title>THE ROLE OF FLOSEAL IN THE PREVENTION OF LYMPHOCELE AND LYMPHATIC ASCITES AFTER LYMPH NODE DISSECTION FOR GYNECOLOGIC CANCER: A RANDOMIZED CONTROLLED TRIAL</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Baxter Healthcare Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the incidence of lymphocele and lymphatic ascites between patient who use versus&#xD;
      who do not use FloSeal during lymph node dissection&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of lymphocele an lymphatic ascites</measure>
    <time_frame>within 1 year after surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time interval from surgery to removal of closed drain system</measure>
    <time_frame>with 2 weeks after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative drain amount</measure>
    <time_frame>with 2 weeks after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative hospital stay</measure>
    <time_frame>within 2 weeks after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative bleeding incidence</measure>
    <time_frame>within 2 weeks after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative complication incidence</measure>
    <time_frame>within 1 month after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>within 1 year after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2-year disease free survival and overall survival</measure>
    <time_frame>2 years after surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Gynecologic Cancer</condition>
  <condition>Cervical Cancer</condition>
  <condition>Endometrial Cancer</condition>
  <condition>Ovarian Cancer</condition>
  <condition>Fallopian Tubal Cancer</condition>
  <arm_group>
    <arm_group_label>FloSeal group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will undergo appropriate cancer surgery for each patient with pelvic lymph node dissection +/- para-aortic lymph node dissection. At the completion of lymph node dissection, 2 vials of Floseal will be applied to each lymph node area.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No FloSeal group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All surgical procedures of control group is the same with study group except that Floseal is not applicated in control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FloSeal application</intervention_name>
    <description>At the completion of lymph node dissection, 2 vials of Floseal will be applied to each lymph node area.</description>
    <arm_group_label>FloSeal group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed primary cancer of the uterine cervix, uterine corpus, ovary,&#xD;
             and fallopian tube&#xD;
&#xD;
          -  FIGO stage Cervical cancer: FIOG stage IA2-IIA2 Uterine cancer: FIGO stage I-III&#xD;
             Ovarian and fallopian tubal cancer: FIGO stage I-IIIB&#xD;
&#xD;
          -  Patients who undergoing surgery including pelvic and/or para-aortic lymph node&#xD;
             dissection&#xD;
&#xD;
          -  Patients with adequate bone marrow, renal and hepatic function:&#xD;
&#xD;
        WBC &gt; 3,000 cells/mcl Platelets &gt;100,000/mcl Creatinine &lt;2.0 mg/dL Bilirubin &lt;1.5 x normal&#xD;
        and SGOT or SGPT &lt;3 x normal&#xD;
&#xD;
          -  American Society of Anesthesiology Physical Status 0-1&#xD;
&#xD;
          -  Performance status of ECOG 0-2&#xD;
&#xD;
          -  Patient must be suitable candidates for surgery&#xD;
&#xD;
          -  Patients who have signed an approved Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of pelvic or abdominal radiotherapy;&#xD;
&#xD;
          -  Patients who are pregnant&#xD;
&#xD;
          -  Patients with contraindications to surgery;&#xD;
&#xD;
          -  Patients who are unfit for Surgery: serious concomitant systemic disorders&#xD;
             incompatible with the study (at the discretion of the investigator);&#xD;
&#xD;
          -  Patient's compliance and geographic proximity that do not allow adequate follow-up.&#xD;
&#xD;
          -  Patients who undergo only lymph node sampling&#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>May 2017</verification_date>
  <study_first_submitted>September 3, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>May 27, 2017</last_update_submitted>
  <last_update_submitted_qc>May 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2017</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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometrial Neoplasms</mesh_term>
    <mesh_term>Lymphocele</mesh_term>
  </condition_browse>
  <!-- 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/NCT01679483
org study id: FloSeal-LND
nct id: NCT01679483
lead sponsor: 
collaborator: 
has dmc: No
To compare the incidence of lymphocele and lymphatic ascites between patient who use versus
      who do not use FloSeal during lymph node dissection
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Incidence of lymphocele an lymphatic ascites
time frame: within 1 year after surgery
measure: Time interval from surgery to removal of closed drain system
time frame: with 2 weeks after surgery
measure: Postoperative drain amount
time frame: with 2 weeks after surgery
measure: Postoperative hospital stay
time frame: within 2 weeks after surgery
measure: Postoperative bleeding incidence
time frame: within 2 weeks after surgery
measure: Postoperative complication incidence
time frame: within 1 month after surgery
measure: Quality of life
time frame: within 1 year after surgery
measure: 2-year disease free survival and overall survival
time frame: 2 years after surgery
arm group label: FloSeal group
arm group type: Experimental
description: This group will undergo appropriate cancer surgery for each patient with pelvic lymph node dissection +/- para-aortic lymph node dissection. At the completion of lymph node dissection, 2 vials of Floseal will be applied to each lymph node area.
arm group label: No FloSeal group
arm group type: No Intervention
description: All surgical procedures of control group is the same with study group except that Floseal is not applicated in control group.
intervention type: Drug
intervention name: FloSeal application
description: At the completion of lymph node dissection, 2 vials of Floseal will be applied to each lymph node area.
arm group label: FloSeal 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
mesh term: Lymphocele