<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/NCT03253588</url>
  </required_header>
  <id_info>
    <org_study_id>106002-E</org_study_id>
    <nct_id>NCT03253588</nct_id>
  </id_info>
  <brief_title>Laparoscopic Tubal Preservation Surgery</brief_title>
  <official_title>Clinical Outcome of Laparoscopic Tubal Preservation Surgery for Ectopic Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Far Eastern Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Far Eastern Memorial 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>
      Traditionally, salpingectomy has been the standard procedure for managing ectopic pregnancy.&#xD;
      We would like to evaluate the safety and efficacy of laparoscopic tubal preservation surgery&#xD;
      in treating ectopic pregnancies (salpingostomy or salpingotomy) while preserving the&#xD;
      fertility outcome of the patients, as well as to identify the factors predicting the presence&#xD;
      of persistent ectopic pregnancy after the surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All surgically-treated ectopic pregnancies in women aged 20 and above between 01 January 2009&#xD;
      and 31 December 2016 were identified. Cases receiving laparoscopic salpingostomy or&#xD;
      laparoscopic salpingotomy were extracted from the database, patient characteristics and&#xD;
      surgical outcomes (changes of serumβ-hcg, presence of persistent ectopic pregnancy and&#xD;
      subsequent management, subsequent pregnancy) were reviewed from their medical records.&#xD;
      Univariate and multivariate logistic regression analysis were employed to predict the&#xD;
      presence of persistent ectopic pregnancy after laparoscopic tubal preservation surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2017</start_date>
  <completion_date type="Actual">October 15, 2017</completion_date>
  <primary_completion_date type="Actual">September 15, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>peri- and post-operative parameters</measure>
    <time_frame>between January 2009 and November 2016</time_frame>
    <description>success rate of tubal preservation surgery (defined by postoperative serum bcg &lt;5 IU/mL), postoperative complications (number of women who had adverse surgical outcome such as bladder injury, bowel injury, massive bleeding), pregnancy outcome (number of women who conceived successfully following the intervention)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>factors affecting the surgical success rate</measure>
    <time_frame>between January 2009 and November 2016</time_frame>
    <description>relationship between patient's baseline characteristics and rate of persistent ectopic pregnancy (unvariate and multivariate analysis)</description>
  </secondary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Ectopic Pregnancy</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>laparoscopic salpingotomy or salpingostomy</intervention_name>
    <description>A 3-port technique (2 x 5-mm and 1 x 10-mm trocars) was implemented. A diluted solution of vasopressin (20IU in 100 mL saline solution) was initially injected into the mesosalpinx of the affected tube, followed by a linear incision which allowed the removal of the gestational tissue. In case of a ruptured tubal pregnancy, the ectopic mass was evacuated directly from the ruptured site using a combination of forceps and suction device. The tubal lumen was either closed with a single-layer of continuous absorbable suture (salpingotomy) or left to heal by secondary intention (salpingostomy).</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        women diagnosed with ectopic pregnancies and underwent laparoscopic tubal preservation&#xD;
        surgery (including salpingostomy and salpingotomy)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women who had laparoscopic tubal preservation surgery (including salpingostomy and&#xD;
             salpingotomy) for ectopic pregnancy between January 2009 and November 2016&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  women with ectopic pregnancy at sites other than fallopian tube (i.e. interstitial,&#xD;
             ovary, abdomen)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Far Eastern Memorial Hospital</name>
      <address>
        <city>Taipei</city>
        <state>New Taipei City</state>
        <zip>220</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>July 29, 2019</last_update_submitted>
  <last_update_submitted_qc>July 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Far Eastern Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Stella Ting Wan Hua</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>Pregnancy, Ectopic</mesh_term>
    <mesh_term>Cardiac Complexes, Premature</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/NCT03253588
org study id: 106002-E
nct id: NCT03253588
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Traditionally, salpingectomy has been the standard procedure for managing ectopic pregnancy.
      We would like to evaluate the safety and efficacy of laparoscopic tubal preservation surgery
      in treating ectopic pregnancies (salpingostomy or salpingotomy) while preserving the
      fertility outcome of the patients, as well as to identify the factors predicting the presence
      of persistent ectopic pregnancy after the surgery.
All surgically-treated ectopic pregnancies in women aged 20 and above between 01 January 2009
      and 31 December 2016 were identified. Cases receiving laparoscopic salpingostomy or
      laparoscopic salpingotomy were extracted from the database, patient characteristics and
      surgical outcomes (changes of serumβ-hcg, presence of persistent ectopic pregnancy and
      subsequent management, subsequent pregnancy) were reviewed from their medical records.
      Univariate and multivariate logistic regression analysis were employed to predict the
      presence of persistent ectopic pregnancy after laparoscopic tubal preservation surgery.
observational model: Case-Control
time perspective: Retrospective
measure: peri- and post-operative parameters
time frame: between January 2009 and November 2016
description: success rate of tubal preservation surgery (defined by postoperative serum bcg <5 IU/mL), postoperative complications (number of women who had adverse surgical outcome such as bladder injury, bowel injury, massive bleeding), pregnancy outcome (number of women who conceived successfully following the intervention)
measure: factors affecting the surgical success rate
time frame: between January 2009 and November 2016
description: relationship between patient's baseline characteristics and rate of persistent ectopic pregnancy (unvariate and multivariate analysis)
intervention type: Procedure
intervention name: laparoscopic salpingotomy or salpingostomy
description: A 3-port technique (2 x 5-mm and 1 x 10-mm trocars) was implemented. A diluted solution of vasopressin (20IU in 100 mL saline solution) was initially injected into the mesosalpinx of the affected tube, followed by a linear incision which allowed the removal of the gestational tissue. In case of a ruptured tubal pregnancy, the ectopic mass was evacuated directly from the ruptured site using a combination of forceps and suction device. The tubal lumen was either closed with a single-layer of continuous absorbable suture (salpingotomy) or left to heal by secondary intention (salpingostomy).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Far Eastern Memorial Hospital
investigator full name: Stella Ting Wan Hua
investigator title: Principal Investigator
mesh term: Pregnancy, Ectopic
mesh term: Cardiac Complexes, Premature
sharing ipd: No