<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/NCT04491305</url>
  </required_header>
  <id_info>
    <org_study_id>PetrovaZg</org_study_id>
    <nct_id>NCT04491305</nct_id>
  </id_info>
  <brief_title>EHP-5 in Preoperative Assessment in Women With Endometriosis</brief_title>
  <acronym>EHP-5CRO</acronym>
  <official_title>Implementation of Endometriosis Health Profile-5 (EHP-5) in Croatian Gynecological Practice for Preoperative Assessment in Women With Endometriosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zagreb</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zagreb</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is no validated tool in quality-of-life assessment of women with endometriosis in&#xD;
      Croatia. First aim is to validate Endometriosis Health Profile-5 (EHP-5) before implementing&#xD;
      this questionnaire in clinical practice. After validation, we will prospectively follow women&#xD;
      with endometriosis through whole process - pre- and postoperatively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is no validated tool in quality-of-life assessment of women with endometriosis in&#xD;
      Croatia. First aim is to validate Endometriosis Health Profile-5 (EHP-5) before implementing&#xD;
      this questionnaire in clinical practice. After validation, we will prospectively follow women&#xD;
      with endometriosis through whole process - pre- and postoperatively, including comparison&#xD;
      with rASRM and Enzian score which are already established in our Clinic.&#xD;
&#xD;
      We will try to identify correlation between EHP-5 score and surgical findings and to provide&#xD;
      better insight in quality of life consideration of women with endometriosis particularly in&#xD;
      Croatia. Since we are tertiary referral centre with almost 250 operative procedures which&#xD;
      include ovarian, pelvic and/or extra pelvic endometriosis, we believe that this study will&#xD;
      bring new tool not only for preoperative assessment but postoperative surveillance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2021</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>EHP-5 score can predict extent of surgical procedure</measure>
    <time_frame>Intraoperative time</time_frame>
    <description>Bigger overall EHP-5 score will be successful predictor of required surgical intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EHP-5 score in postoperative surveillance</measure>
    <time_frame>Postoperative routine surveillance at two different time points - 6 weeks and 6 months after operation</time_frame>
    <description>We assume that EHP-5 score can be used as a postoperative surveillance indicator</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Endometriosis</condition>
  <condition>Endometriosis Ovary</condition>
  <condition>Endometriosis-related Pain</condition>
  <condition>Quality of Life</condition>
  <condition>Endometrioma</condition>
  <condition>Endometriosis, Rectum</condition>
  <arm_group>
    <arm_group_label>Women with pathohistological confirmation</arm_group_label>
    <description>Women aged between 18 and 50 with surgically proven endometriosis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgically treated women with endometriosis and confirmed diagnosis</intervention_name>
    <description>Women with indication for surgery or diagnostic laparoscopy will be enrolled in study.</description>
    <arm_group_label>Women with pathohistological confirmation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We will include at least 100 women with surgically proven endometriosis in order to&#xD;
        establish EHP-5 in our clinical practice.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged between 18 and 50 years; symptoms of endometriosis (pelvic pain, dyspareunia,&#xD;
             dysmenorrhea) for at least 6 months or previously verified primary sterility;&#xD;
             pathohistological confirmation of diagnosis after surgical treatment or indicated&#xD;
             diagnostic laparoscopy; fluent and literate in Croatian language; ability to&#xD;
             independently understand the questions in the questionnaires&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant women; cognitive impairment or intellectual disability; neurological&#xD;
             disorders (e.g. epilepsy, Parkinson disease, multiple sclerosis, cerebrovascular&#xD;
             insult); lack of independent mobility and polytraumatic patients; diagnosed vulvodynia&#xD;
             and active vulvovaginitis; ongoing urinary tract infection; any form of prior&#xD;
             conservative and/or surgical treatment for endometriosis; lack of informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mislav Mikuš, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Center Zagreb, Croatia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mislav Mikuš, MD</last_name>
    <phone>+385994006639</phone>
    <email>m.mikus19@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Clinical Hospital Centre Zagreb, Croatia</name>
      <address>
        <city>Zagreb</city>
        <zip>10 000</zip>
        <country>Croatia</country>
      </address>
    </facility>
    <contact>
      <last_name>Mislav Mikuš, MD</last_name>
      <phone>+ 385 1 460 4646</phone>
      <email>m.mikus19@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Croatia</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 25, 2020</last_update_submitted>
  <last_update_submitted_qc>July 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Zagreb</investigator_affiliation>
    <investigator_full_name>Mislav Mikuš</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>endometriosis</keyword>
  <keyword>quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</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/NCT04491305
org study id: PetrovaZg
nct id: NCT04491305
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
There is no validated tool in quality-of-life assessment of women with endometriosis in
      Croatia. First aim is to validate Endometriosis Health Profile-5 (EHP-5) before implementing
      this questionnaire in clinical practice. After validation, we will prospectively follow women
      with endometriosis through whole process - pre- and postoperatively.
There is no validated tool in quality-of-life assessment of women with endometriosis in
      Croatia. First aim is to validate Endometriosis Health Profile-5 (EHP-5) before implementing
      this questionnaire in clinical practice. After validation, we will prospectively follow women
      with endometriosis through whole process - pre- and postoperatively, including comparison
      with rASRM and Enzian score which are already established in our Clinic.

      We will try to identify correlation between EHP-5 score and surgical findings and to provide
      better insight in quality of life consideration of women with endometriosis particularly in
      Croatia. Since we are tertiary referral centre with almost 250 operative procedures which
      include ovarian, pelvic and/or extra pelvic endometriosis, we believe that this study will
      bring new tool not only for preoperative assessment but postoperative surveillance.
observational model: Cohort
time perspective: Prospective
measure: EHP-5 score can predict extent of surgical procedure
time frame: Intraoperative time
description: Bigger overall EHP-5 score will be successful predictor of required surgical intervention
measure: EHP-5 score in postoperative surveillance
time frame: Postoperative routine surveillance at two different time points - 6 weeks and 6 months after operation
description: We assume that EHP-5 score can be used as a postoperative surveillance indicator
arm group label: Women with pathohistological confirmation
description: Women aged between 18 and 50 with surgically proven endometriosis.
intervention type: Procedure
intervention name: Surgically treated women with endometriosis and confirmed diagnosis
description: Women with indication for surgery or diagnostic laparoscopy will be enrolled in study.
arm group label: Women with pathohistological confirmation
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Mislav Mikuš, MD
role: Principal Investigator
affiliation: University Hospital Center Zagreb, Croatia
last name: Mislav Mikuš, MD
phone: +385994006639
email: m.mikus19@gmail.com
facility: 
contact: 
country: Croatia
responsible party type: Principal Investigator
investigator affiliation: University of Zagreb
investigator full name: Mislav Mikuš
investigator title: MD
mesh term: Endometriosis
sharing ipd: No