<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/NCT03769584</url>
  </required_header>
  <id_info>
    <org_study_id>2018-01728; sp18Tschudin</org_study_id>
    <nct_id>NCT03769584</nct_id>
  </id_info>
  <brief_title>Follow-up of Treatment Outcome, Quality of Life, Sexual Life and Partnership After Surgery of Endometriosis</brief_title>
  <official_title>Follow-up of Treatment Outcome, Quality of Life, Sexual Life and Partnership After Surgery of Endometriosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</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>
      Follow-up of treatment outcome, quality of life, sexual life and partnership after surgery of&#xD;
      endometriosis by means of a questionnaire 1 year after surgical Intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 15, 2018</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">April 9, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Endometriosis- associated symptoms assessed by questionnaire</measure>
    <time_frame>1 year after surgery of endometriosis</time_frame>
    <description>questionnaire asking for pain (with menstruation, with sexual intercourse, with defecation, with urination) on a Visual Analogue Scale (VAS), ranging from 0 = no pain to 10 = intolerable pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment outcome of surgery of endometriosis assessed by VAS questionnaire</measure>
    <time_frame>1 year after surgery of endometriosis</time_frame>
    <description>questionnaire asking for satisfaction with treatment outcome on a Visual Analogue Scale (VAS), ranging from 0 = absolutely dissatisfied to 10 = absolutely satisfied</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Quality of life assessed by questionnaire</measure>
    <time_frame>before surgery of endometriosis and 1 year after surgery of endometriosis</time_frame>
    <description>questionnaire asking for Quality of life on a Visual Analogue Scale (VAS), ranging from 0 = very bad to 10 = very good</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in sexual life assessed by questionnaire</measure>
    <time_frame>before surgery of endometriosis and 1 year after surgery of endometriosis</time_frame>
    <description>questionnaire asking for Sexual life on a Visual Analogue Scale (VAS), ranging from 0 = absolutely dissatisfied to 10 = absolutely satisfied</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in conduct of life assessed by questionnaire</measure>
    <time_frame>before surgery of endometriosis and 1 year after surgery of endometriosis</time_frame>
    <description>questionnaire asking for change in conduct of life (partnership, family, professional life, leisure activity, sportive activities) on a 6- item scale (ranging from &quot;negative&quot; to &quot;positive&quot;)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in wish for child assessed by questionnaire</measure>
    <time_frame>before surgery of endometriosis and 1 year after surgery of endometriosis</time_frame>
    <description>questionnaire asking for change in wish for child on a 3- item scale (ranging from &quot;yes&quot; , &quot;no answer&quot; to &quot;no&quot;)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Follow-up of Treatment outcome of surgery of endometriosis assessed by interview</measure>
    <time_frame>1 year after surgery of endometriosis</time_frame>
    <description>semi- structured interview to assess comments of study participants that are not depicted in the questionnaires</description>
  </secondary_outcome>
  <enrollment type="Actual">31</enrollment>
  <condition>Endometriosis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Follow-up questionnaire</intervention_name>
    <description>Online- Questionnaire investigating Follow-up of Treatment Outcome, Quality of Life, Sexual Life and Partnership After Surgery of Endometriosis</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Follow- up interview</intervention_name>
    <description>Semi- structured Interview investigating Follow-up of Treatment Outcome, Quality of Life, Sexual Life and Partnership After Surgery of Endometriosis</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        women with endometriosis undergoing surgery of endometriosis at Frauenklinik of University&#xD;
        Hospital Basel (from 01.01.2017 until 31.12.2017)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  surgery of endometriosis at Frauenklinik of University Hospital Basel (from 01.01.2017&#xD;
             until 31.12.2017)&#xD;
&#xD;
          -  sufficient German language skills in order to be able to complete questionnaires&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  incapable of consenting&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sibil Tschudin, PD Dr. med</last_name>
    <role>Principal Investigator</role>
    <affiliation>Frauenklinik Universitätsspital Basel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Frauenklinik University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>January 29, 2020</last_update_submitted>
  <last_update_submitted_qc>January 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>quality of life</keyword>
  <keyword>treatment outcome</keyword>
  <keyword>sexuality</keyword>
  <keyword>partnership</keyword>
  <keyword>surgery of endometriosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</mesh_term>
  </condition_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/NCT03769584
org study id: 2018-01728; sp18Tschudin
nct id: NCT03769584
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Follow-up of treatment outcome, quality of life, sexual life and partnership after surgery of
      endometriosis by means of a questionnaire 1 year after surgical Intervention.
observational model: Cohort
time perspective: Retrospective
measure: Endometriosis- associated symptoms assessed by questionnaire
time frame: 1 year after surgery of endometriosis
description: questionnaire asking for pain (with menstruation, with sexual intercourse, with defecation, with urination) on a Visual Analogue Scale (VAS), ranging from 0 = no pain to 10 = intolerable pain
measure: Treatment outcome of surgery of endometriosis assessed by VAS questionnaire
time frame: 1 year after surgery of endometriosis
description: questionnaire asking for satisfaction with treatment outcome on a Visual Analogue Scale (VAS), ranging from 0 = absolutely dissatisfied to 10 = absolutely satisfied
measure: Change in Quality of life assessed by questionnaire
time frame: before surgery of endometriosis and 1 year after surgery of endometriosis
description: questionnaire asking for Quality of life on a Visual Analogue Scale (VAS), ranging from 0 = very bad to 10 = very good
measure: Change in sexual life assessed by questionnaire
time frame: before surgery of endometriosis and 1 year after surgery of endometriosis
description: questionnaire asking for Sexual life on a Visual Analogue Scale (VAS), ranging from 0 = absolutely dissatisfied to 10 = absolutely satisfied
measure: Change in conduct of life assessed by questionnaire
time frame: before surgery of endometriosis and 1 year after surgery of endometriosis
description: questionnaire asking for change in conduct of life (partnership, family, professional life, leisure activity, sportive activities) on a 6- item scale (ranging from "negative" to "positive")
measure: Change in wish for child assessed by questionnaire
time frame: before surgery of endometriosis and 1 year after surgery of endometriosis
description: questionnaire asking for change in wish for child on a 3- item scale (ranging from "yes" , "no answer" to "no")
measure: Follow-up of Treatment outcome of surgery of endometriosis assessed by interview
time frame: 1 year after surgery of endometriosis
description: semi- structured interview to assess comments of study participants that are not depicted in the questionnaires
intervention type: Other
intervention name: Follow-up questionnaire
description: Online- Questionnaire investigating Follow-up of Treatment Outcome, Quality of Life, Sexual Life and Partnership After Surgery of Endometriosis
intervention type: Other
intervention name: Follow- up interview
description: Semi- structured Interview investigating Follow-up of Treatment Outcome, Quality of Life, Sexual Life and Partnership After Surgery of Endometriosis
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sibil Tschudin, PD Dr. med
role: Principal Investigator
affiliation: Frauenklinik Universitätsspital Basel
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Endometriosis