<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/NCT01683877</url>
  </required_header>
  <id_info>
    <org_study_id>FloSeal-OC</org_study_id>
    <nct_id>NCT01683877</nct_id>
  </id_info>
  <brief_title>Efficacy Study of FloSeal in Hemostasis After Laparoscopic Ovarian Cystectomy</brief_title>
  <official_title>PROSPECTIVE RANDOMIZED CONPARISON OF ELECTRONIC DIATHERMY VERSUS FLOSEAL IN HEMOSTASIS AFTER LAPAROSCOPIC OVARIAN CYSTECTOMY</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 efficacy in postoperative hemostasis and in sparing postoperative ovarian&#xD;
      function between FloSeal and Electrocauterization in laparoscopic ovarian cystectomy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hemostasis time</measure>
    <time_frame>Immediately after operation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ovarian function after surgery</measure>
    <time_frame>within 6 months after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative time</measure>
    <time_frame>1 day (Immediately after surgery)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative blood loss</measure>
    <time_frame>During surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative drainage volume</measure>
    <time_frame>within 2 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative drainage duration</measure>
    <time_frame>within 1 week after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of postoperative stay</measure>
    <time_frame>within 1 month after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>within 1 months after surgery</time_frame>
    <description>Postoperative complications will be evaluated with Dindo's classification for postoperative complication and CTCAE v4.0.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Benign Ovarian Tumor</condition>
  <arm_group>
    <arm_group_label>FloSeal group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Electrocautery group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>FloSeal application</intervention_name>
    <description>After laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy)</description>
    <arm_group_label>FloSeal group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Electrocautery</intervention_name>
    <description>After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery</description>
    <arm_group_label>Electrocautery group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Premenopausal women&#xD;
&#xD;
          -  Patients who is planned to undergo laparoscopic ovarian cystectomy&#xD;
&#xD;
          -  American Society of Anesthesiologists Physical Status classification (ASA PS) 1-2&#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;
          -  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 or nursing&#xD;
&#xD;
          -  Patients who is receiving or requires hormone replacement therapy after surgery&#xD;
&#xD;
          -  Patients who is undergoing hysterectomy at this time&#xD;
&#xD;
          -  Patients who is undergoing unilateral or bilateral oophorectomy&#xD;
&#xD;
          -  Previous history of ovarian cystectomy or oophorectomy&#xD;
&#xD;
          -  Patients with contraindications to surgery&#xD;
&#xD;
          -  Unfit for Surgery: serious concomitant systemic disorders incompatible with the study&#xD;
             (at the discretion of the investigator)&#xD;
&#xD;
          -  Patient compliance and geographic proximity that do not allow adequate follow-up.&#xD;
&#xD;
          -  Hormone therapy within 3 months before 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>
  <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 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 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>Ovarian Neoplasms</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/NCT01683877
org study id: FloSeal-OC
nct id: NCT01683877
lead sponsor: 
collaborator: 
has dmc: No
To compare the efficacy in postoperative hemostasis and in sparing postoperative ovarian
      function between FloSeal and Electrocauterization in laparoscopic ovarian cystectomy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Hemostasis time
time frame: Immediately after operation
measure: Ovarian function after surgery
time frame: within 6 months after surgery
measure: Operative time
time frame: 1 day (Immediately after surgery)
measure: Intraoperative blood loss
time frame: During surgery
measure: Postoperative drainage volume
time frame: within 2 days after surgery
measure: Postoperative drainage duration
time frame: within 1 week after surgery
measure: Length of postoperative stay
time frame: within 1 month after surgery
measure: Postoperative complications
time frame: within 1 months after surgery
description: Postoperative complications will be evaluated with Dindo's classification for postoperative complication and CTCAE v4.0.
arm group label: FloSeal group
arm group type: Experimental
description: After laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy)
arm group label: Electrocautery group
arm group type: Active Comparator
description: After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery
intervention type: Procedure
intervention name: FloSeal application
description: After laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy)
arm group label: FloSeal group
intervention type: Procedure
intervention name: Electrocautery
description: After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery
arm group label: Electrocautery 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: Ovarian Neoplasms