<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/NCT03009812</url>
  </required_header>
  <id_info>
    <org_study_id>MY-789</org_study_id>
    <nct_id>NCT03009812</nct_id>
  </id_info>
  <brief_title>Transverse vs Longitudinal Incision in Myomectomy</brief_title>
  <official_title>Transverse Versus Longitudinal Uterine Incision in Abdominal Myomectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Aim of the study is to compare between transverse and longitudinal uterine incision in&#xD;
      abdominal myomectomy regarding intraoperative blood loss.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">January 23, 2018</completion_date>
  <primary_completion_date type="Actual">January 2018</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>Intraoperative blood loss</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Myoma;Uterus</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>26 subjects who are planned for transverse uterine incision</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>26 subjects who are planned for longitudinal uterine incision</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Longitudinal uterine incision</intervention_name>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transverse uterine incision</intervention_name>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Inclusion criteria for myomectomy as; abnormal uterine, pressure related symptoms,&#xD;
             infertility and recurrent pregnancy loss in patients between 18 and 45 years old&#xD;
&#xD;
          2. Single myoma.&#xD;
&#xD;
          3. Women with BMI between 18.5-29.9 kg/m2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy.&#xD;
&#xD;
          2. Patients with bleeding tendency&#xD;
&#xD;
          3. Previous laparotomies.&#xD;
&#xD;
          4. Patients with concomitant pelvic pathologies, such as ovarian cysts.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 1, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>April 5, 2019</last_update_submitted>
  <last_update_submitted_qc>April 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>maii medhat nawara</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leiomyoma</mesh_term>
    <mesh_term>Myofibroma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03009812
org study id: MY-789
nct id: NCT03009812
lead sponsor: 
has dmc: No
The Aim of the study is to compare between transverse and longitudinal uterine incision in
      abdominal myomectomy regarding intraoperative blood loss.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Intraoperative blood loss
time frame: 1 year
arm group label: Group 1
arm group type: Active Comparator
description: 26 subjects who are planned for transverse uterine incision
arm group label: Group 2
arm group type: Active Comparator
description: 26 subjects who are planned for longitudinal uterine incision
intervention type: Procedure
intervention name: Longitudinal uterine incision
arm group label: Group 2
intervention type: Procedure
intervention name: Transverse uterine incision
arm group label: Group 1
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: maii medhat nawara
investigator title: Principle investigator
mesh term: Leiomyoma
mesh term: Myofibroma
sharing ipd: No