<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/NCT03830502</url>
  </required_header>
  <id_info>
    <org_study_id>EtfalSalp</org_study_id>
    <nct_id>NCT03830502</nct_id>
  </id_info>
  <brief_title>Driving Factors of Decision Making for Prophylactic Salpingectomy Versus Tubal Ligation at the Time of Cesarean Section</brief_title>
  <official_title>Driving Factors of Decision Making for Prophylactic Salpingectomy Versus Tubal Ligation at the Time of Cesarean Section</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bartin State Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bartin State Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      Prophylactic (Opportunistic) salpingectomy is a cost-effective strategy recommended for&#xD;
      reducing the risk of ovarian cancer at the time of gynecologic surgery in women who have&#xD;
      completed childbearing. Similar evidence for cesarean section is growing. However,&#xD;
      salpingectomy refers to the surgical removal of a female reproductive organ. Some women may&#xD;
      have hesitations about salpingectomy with regard to religious concerns, reduced self-image,&#xD;
      tubal reanastomosis or lack of knowledge.&#xD;
&#xD;
      The investigators aimed to explore the underlying factors that motivate women for either&#xD;
      decisions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prophylactic and opportunistic bilateral salpingectomy is an increasing trend among surgeons&#xD;
      and also proven as an effective risk-reducing method for ovarian cancer.&#xD;
&#xD;
      The investigators have experienced denials among women who were seeking tubal ligation as a&#xD;
      sterilization procedure during cesarean section after a comprehensive counseling for&#xD;
      prophylactic salpingectomy. Therefore, the investigators aimed to assess the driving factors&#xD;
      of decision making for prophylactic salpingectomy or tubal ligation. It is planned to&#xD;
      preoperatively have a non-validated questionnaire for the women after a detailed briefing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 10, 2019</start_date>
  <completion_date type="Actual">February 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 10, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Motivators for sterilization type</measure>
    <time_frame>Evaluation at preoperative 32th gestational weeks</time_frame>
    <description>A non-validated data collection tool with open-ended questions assessing the factors behind the decision of salpingectomy or tubal ligation. Data collection tool questions why patients choosed or refused salpingectomy in detail. It is not a scale and does not have a range.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">58</enrollment>
  <condition>Salpingectomy</condition>
  <condition>Sterilization, Tubal</condition>
  <arm_group>
    <arm_group_label>Salpingectomy</arm_group_label>
    <description>Women who gave consent for opportunistic prophylactic bilateral salpingectomy during cesarean section as a Surgical sterilization procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tubal ligation</arm_group_label>
    <description>Women who refused salpingectomy and gave consent for tubal ligation during cesarean section as a Surgical sterilization procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical sterilization</intervention_name>
    <description>Surgical sterilization either standard salpingectomy or tubal ligation with Pomeroy technique</description>
    <arm_group_label>Salpingectomy</arm_group_label>
    <arm_group_label>Tubal ligation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women who aged over 18 years old and seek for sterilization at the time of cesarean&#xD;
        section.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women seeking for surgical sterilization during their cesarean section&#xD;
&#xD;
          -  Elective and Category 2 or more planned cesarean sections&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical conditions that lead to planned cesarean hysterectomy such as placenta&#xD;
             percreata&#xD;
&#xD;
          -  History of ovarian cancer, previous chemotherapy or radiation&#xD;
&#xD;
          -  Women who previously underwent sterilization&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Murat Yassa, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Specialist</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bartin State Hospital</name>
      <address>
        <city>Bartin</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istanbul Sisli Hamidiye Etfal Training And Research Hospital, Health Sciences University</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medicalpark Gaziosmanpasa Hospital, Istinye University</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Zamorano AS, Mutch DG. Postpartum salpingectomy: a procedure whose time has come. Am J Obstet Gynecol. 2019 Jan;220(1):8-9. doi: 10.1016/j.ajog.2018.09.041. No abstract available.</citation>
    <PMID>30591122</PMID>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>February 3, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>April 29, 2020</last_update_submitted>
  <last_update_submitted_qc>April 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bartin State Hospital</investigator_affiliation>
    <investigator_full_name>Murat Yassa</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Prophylactic salpingectomy</keyword>
  <keyword>Opportunistic salpingectomy</keyword>
  <keyword>Risk-reducing</keyword>
  <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/NCT03830502
org study id: EtfalSalp
nct id: NCT03830502
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prophylactic (Opportunistic) salpingectomy is a cost-effective strategy recommended for
      reducing the risk of ovarian cancer at the time of gynecologic surgery in women who have
      completed childbearing. Similar evidence for cesarean section is growing. However,
      salpingectomy refers to the surgical removal of a female reproductive organ. Some women may
      have hesitations about salpingectomy with regard to religious concerns, reduced self-image,
      tubal reanastomosis or lack of knowledge.

      The investigators aimed to explore the underlying factors that motivate women for either
      decisions.
Prophylactic and opportunistic bilateral salpingectomy is an increasing trend among surgeons
      and also proven as an effective risk-reducing method for ovarian cancer.

      The investigators have experienced denials among women who were seeking tubal ligation as a
      sterilization procedure during cesarean section after a comprehensive counseling for
      prophylactic salpingectomy. Therefore, the investigators aimed to assess the driving factors
      of decision making for prophylactic salpingectomy or tubal ligation. It is planned to
      preoperatively have a non-validated questionnaire for the women after a detailed briefing.
observational model: Cohort
time perspective: Prospective
measure: Motivators for sterilization type
time frame: Evaluation at preoperative 32th gestational weeks
description: A non-validated data collection tool with open-ended questions assessing the factors behind the decision of salpingectomy or tubal ligation. Data collection tool questions why patients choosed or refused salpingectomy in detail. It is not a scale and does not have a range.
arm group label: Salpingectomy
description: Women who gave consent for opportunistic prophylactic bilateral salpingectomy during cesarean section as a Surgical sterilization procedure
arm group label: Tubal ligation
description: Women who refused salpingectomy and gave consent for tubal ligation during cesarean section as a Surgical sterilization procedure
intervention type: Procedure
intervention name: Surgical sterilization
description: Surgical sterilization either standard salpingectomy or tubal ligation with Pomeroy technique
arm group label: Salpingectomy
arm group label: Tubal ligation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Murat Yassa, M.D.
role: Principal Investigator
affiliation: Specialist
facility: 
facility: 
facility: 
country: Turkey
citation: Zamorano AS, Mutch DG. Postpartum salpingectomy: a procedure whose time has come. Am J Obstet Gynecol. 2019 Jan;220(1):8-9. doi: 10.1016/j.ajog.2018.09.041. No abstract available.
PMID: 30591122
responsible party type: Principal Investigator
investigator affiliation: Bartin State Hospital
investigator full name: Murat Yassa
investigator title: Principal Investigator
sharing ipd: No