<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/NCT01715597</url>
  </required_header>
  <id_info>
    <org_study_id>SNUBH_GO_016</org_study_id>
    <nct_id>NCT01715597</nct_id>
  </id_info>
  <brief_title>Study on the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women With Uterine Myoma</brief_title>
  <official_title>Placebo-controlled,Doubled,Randomized Trial Evaluating the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women Undergoing Laparoscopic Myomectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators want to know whether the intravenous ascorbic acid would reduce the blood&#xD;
      loss during laparoscopic myoma surgery. The investigators randomized patients into&#xD;
      intravenous ascorbic acid group and placebo group and examined the blood loss in both groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">October 2017</primary_completion_date>
  <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>blood loss</measure>
    <time_frame>during laparoscopic myomectomy</time_frame>
  </primary_outcome>
  <other_outcome>
    <measure>time of operation</measure>
    <time_frame>during laparoscopic myomectomy</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>the amount of transfusion</measure>
    <time_frame>during laparoscopic myomectomy</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>the difference of hemoglobin</measure>
    <time_frame>postoperative day 1</time_frame>
    <description>postoperative day 1 hemoglobin - preoperative hemoglobin + hemoglobin increased by transfusion (hemoglobin 1 per RBC 1 pack transfusion)</description>
  </other_outcome>
  <other_outcome>
    <measure>acute urinary retention</measure>
    <time_frame>2days after the operation</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Uterine Leiomyoma</condition>
  <arm_group>
    <arm_group_label>ascorbic acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ascorbic acid 2g in normal saline 500ml IV start 2hours before the operation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal saline 500ml IV infusion for 2hour</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ascorbic acid</intervention_name>
    <description>ascorbic acid 2g in normal saline 500ml IV start 30min before the operation and infusion for 2 hour</description>
    <arm_group_label>ascorbic acid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>normal saline 500ml IV</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>ascorbic acid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  uterine myoma&#xD;
&#xD;
          -  be planning to laparoscopic myomectomy&#xD;
&#xD;
          -  images ; the number of myoma &lt;4&#xD;
&#xD;
          -  images ; the diameter of the largest myoma &lt;9cm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  be planning other surgery in addition to laparoscopy&#xD;
&#xD;
          -  clinically significant coagulation abnormality&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>kiding kim, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital,Gyeongg-ido,Republic of Korea</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Gyeongg-ido</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>October 28, 2017</last_update_submitted>
  <last_update_submitted_qc>October 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Kidong Kim</investigator_full_name>
    <investigator_title>Assistant professor in department of OBGY</investigator_title>
  </responsible_party>
  <keyword>uterine leiomyoma</keyword>
  <keyword>laparoscopic myomectomy</keyword>
  <keyword>intraoperative blood loss</keyword>
  <keyword>ascorbic acid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leiomyoma</mesh_term>
    <mesh_term>Myofibroma</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ascorbic Acid</mesh_term>
  </intervention_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/NCT01715597
org study id: SNUBH_GO_016
nct id: NCT01715597
lead sponsor: 
has dmc: No
The investigators want to know whether the intravenous ascorbic acid would reduce the blood
      loss during laparoscopic myoma surgery. The investigators randomized patients into
      intravenous ascorbic acid group and placebo group and examined the blood loss in both groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: blood loss
time frame: during laparoscopic myomectomy
measure: time of operation
time frame: during laparoscopic myomectomy
measure: the amount of transfusion
time frame: during laparoscopic myomectomy
measure: the difference of hemoglobin
time frame: postoperative day 1
description: postoperative day 1 hemoglobin - preoperative hemoglobin + hemoglobin increased by transfusion (hemoglobin 1 per RBC 1 pack transfusion)
measure: acute urinary retention
time frame: 2days after the operation
arm group label: ascorbic acid
arm group type: Experimental
description: ascorbic acid 2g in normal saline 500ml IV start 2hours before the operation
arm group label: Control
arm group type: Placebo Comparator
description: Normal saline 500ml IV infusion for 2hour
intervention type: Drug
intervention name: ascorbic acid
description: ascorbic acid 2g in normal saline 500ml IV start 30min before the operation and infusion for 2 hour
arm group label: ascorbic acid
intervention type: Drug
intervention name: Normal saline
description: normal saline 500ml IV
arm group label: Control
arm group label: ascorbic acid
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: kiding kim, M.D.
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital,Gyeongg-ido,Republic of Korea
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Kidong Kim
investigator title: Assistant professor in department of OBGY
mesh term: Leiomyoma
mesh term: Myofibroma
mesh term: Hemorrhage
mesh term: Ascorbic Acid