<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/NCT03788421</url>
  </required_header>
  <id_info>
    <org_study_id>0427 - 18 - RMB</org_study_id>
    <nct_id>NCT03788421</nct_id>
  </id_info>
  <brief_title>Comparison Between 2 Techniques for Bilateral Salpingectomy</brief_title>
  <official_title>Comparison Between 2 Techniques for Bilateral Salpingectomy During Cesarean Section</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rambam Health Care Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rambam Health Care Campus</source>
  <oversight_info>
    <has_dmc>Yes</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>
      A comparison between 2 techniques for bilateral salpingectomy during cesarean section.&#xD;
&#xD;
      Primary outcomes are total operative time and bilateral completion of the randomized&#xD;
      procedure. Secondary outcomes included surgical complications and post operation&#xD;
      complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ovarian cancer is the most lethal gynecologic malignancy. Major contributors to this high&#xD;
      mortality are the lack of effective screening strategies, diagnosis at advanced stage of&#xD;
      presentation as well as the high risk of recurrence. In the last years the Gynecologic&#xD;
      Associations worldwide have recommended that total salpingectomy be considered for potential&#xD;
      ovarian cancer risk reduction in benign gynecologic surgeries after completion of&#xD;
      childbearing.&#xD;
&#xD;
      However, the data are limit regarding the Preferred surgical technique during cesarean&#xD;
      section.&#xD;
&#xD;
      In this randomized controled trial the investigators will compare between various techniques&#xD;
      for bilateral salpingectomy during cesarean section.&#xD;
&#xD;
      Primary outcomes are total operative time and bilateral completion of the randomized&#xD;
      procedure. Secondary outcomes included surgical complications and post operation&#xD;
      complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">September 1, 2021</completion_date>
  <primary_completion_date type="Actual">January 1, 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>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total salpingectomy time.</measure>
    <time_frame>Up to 1 week from recruitment</time_frame>
    <description>Time in minutes from beginning of salpingectomy procedure until end of the salpingectomy procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bleeding during salpingectomy</measure>
    <time_frame>Up to 4 hours from the beginning of the procedure</time_frame>
    <description>Estimated amount of bleeding in milliliters during the salpingectomy procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding during cesarean section</measure>
    <time_frame>Up to 4 hours from the beginning of the procedure</time_frame>
    <description>Estimated amount of bleeding in milliliters during the whole cesarean section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin level</measure>
    <time_frame>Up to 5 days from surgery</time_frame>
    <description>Changes in hemoglobin level before and after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood transfusion rate</measure>
    <time_frame>Up to 5 days from surgery</time_frame>
    <description>The rate of blood transfusion post cesarean section</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative stay</measure>
    <time_frame>Up to 2 weeks from surgery</time_frame>
    <description>The length of maternal postoperative stay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analogue score</measure>
    <time_frame>Up to 2 weeks from surgery</time_frame>
    <description>Pain scoring between 0-10 post-surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound complications</measure>
    <time_frame>Up to 2 weeks from surgery</time_frame>
    <description>The rate of wound complications postpartum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for opioids</measure>
    <time_frame>Up to 2 weeks from surgery</time_frame>
    <description>The rate of opioid treatment postpartum</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Sterility, Female</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women undergoing elective bilateral salpingectomy during cesarean section with LIGASURE.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women undergoing elective bilateral salpingectomy during cesarean section with traditional step by step clamping and suturing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LIGASURE</intervention_name>
    <description>Electricity based cautery tool used during both laparoscopic and open surgery for optimal hemostasis.</description>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Clamping and suturing</intervention_name>
    <description>Step by step clamping and suturing of the mesosalpinx until achievement of total salpingectomy.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants undergoing elective Cesarean Section and are interested and have signed&#xD;
             informed consent regarding bilateral salpingectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give informed consent.&#xD;
&#xD;
          -  Preterm delivery (&lt; 37 weeks' gestation).&#xD;
&#xD;
          -  Fetal demise.&#xD;
&#xD;
          -  Prenatal diagnosis of fetal or placental abnormalities.&#xD;
&#xD;
          -  Previous tubal surgery.&#xD;
&#xD;
          -  The use of anticoagulants.&#xD;
&#xD;
          -  Associated immunosuppressive conditions.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yaniv Zipori, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rambam healthcare campus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rambam health care campus</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>December 25, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>February 22, 2022</last_update_submitted>
  <last_update_submitted_qc>February 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rambam Health Care Campus</investigator_affiliation>
    <investigator_full_name>Yaniv Zipori MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Female</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/NCT03788421
org study id: 0427 - 18 - RMB
nct id: NCT03788421
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A comparison between 2 techniques for bilateral salpingectomy during cesarean section.

      Primary outcomes are total operative time and bilateral completion of the randomized
      procedure. Secondary outcomes included surgical complications and post operation
      complications.
Ovarian cancer is the most lethal gynecologic malignancy. Major contributors to this high
      mortality are the lack of effective screening strategies, diagnosis at advanced stage of
      presentation as well as the high risk of recurrence. In the last years the Gynecologic
      Associations worldwide have recommended that total salpingectomy be considered for potential
      ovarian cancer risk reduction in benign gynecologic surgeries after completion of
      childbearing.

      However, the data are limit regarding the Preferred surgical technique during cesarean
      section.

      In this randomized controled trial the investigators will compare between various techniques
      for bilateral salpingectomy during cesarean section.

      Primary outcomes are total operative time and bilateral completion of the randomized
      procedure. Secondary outcomes included surgical complications and post operation
      complications.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Care Provider)
measure: Total salpingectomy time.
time frame: Up to 1 week from recruitment
description: Time in minutes from beginning of salpingectomy procedure until end of the salpingectomy procedure.
measure: Bleeding during salpingectomy
time frame: Up to 4 hours from the beginning of the procedure
description: Estimated amount of bleeding in milliliters during the salpingectomy procedure
measure: Bleeding during cesarean section
time frame: Up to 4 hours from the beginning of the procedure
description: Estimated amount of bleeding in milliliters during the whole cesarean section.
measure: Hemoglobin level
time frame: Up to 5 days from surgery
description: Changes in hemoglobin level before and after surgery
measure: Blood transfusion rate
time frame: Up to 5 days from surgery
description: The rate of blood transfusion post cesarean section
measure: Postoperative stay
time frame: Up to 2 weeks from surgery
description: The length of maternal postoperative stay.
measure: Visual analogue score
time frame: Up to 2 weeks from surgery
description: Pain scoring between 0-10 post-surgery
measure: Wound complications
time frame: Up to 2 weeks from surgery
description: The rate of wound complications postpartum.
measure: Need for opioids
time frame: Up to 2 weeks from surgery
description: The rate of opioid treatment postpartum
arm group label: Study group
arm group type: Active Comparator
description: Women undergoing elective bilateral salpingectomy during cesarean section with LIGASURE.
arm group label: Control group
arm group type: Active Comparator
description: Women undergoing elective bilateral salpingectomy during cesarean section with traditional step by step clamping and suturing.
intervention type: Device
intervention name: LIGASURE
description: Electricity based cautery tool used during both laparoscopic and open surgery for optimal hemostasis.
arm group label: Study group
intervention type: Procedure
intervention name: Clamping and suturing
description: Step by step clamping and suturing of the mesosalpinx until achievement of total salpingectomy.
arm group label: Control group
criteria: 
gender: Female
gender based: Yes
gender description: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Yaniv Zipori, MD
role: Principal Investigator
affiliation: Rambam healthcare campus
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Rambam Health Care Campus
investigator full name: Yaniv Zipori MD
investigator title: Principal Investigator
mesh term: Infertility
mesh term: Infertility, Female
sharing ipd: No