xml: <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/NCT05989516</url>
    </required_header>
    <id_info>
      <org_study_id>001/0/2023</org_study_id>
      <nct_id>NCT05989516</nct_id>
    </id_info>
    <brief_title>Surgical Treatment of Hydatid Liver Disease</brief_title>
    <official_title>Cyst Extraction With Pericyst Reduction and Omentopexy as a Treatment of Choice for Hydatid Liver Disease Caused by E. Granulosus: Retrospective Observational Review of a Single Center Experience</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital for Surgical Diseases St. Naum Ohridsk i- Skopje</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital for Surgical Diseases St. Naum Ohridsk i- Skopje</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>
        The goal of this observational study is to show that cyst extraction with pericyst reduction&#xD;
        and omentopexy is a suitable treatment for liver hydatid disease caused by E.Granulossus with&#xD;
        a low rate of complication and recurrence.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2021</start_date>
    <completion_date type="Actual">March 1, 2023</completion_date>
    <primary_completion_date type="Actual">February 1, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Post operative complications</measure>
      <time_frame>one month</time_frame>
      <description>Listing of complications according to Clavien -Dindo classification</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Recurrence rate</measure>
      <time_frame>5 years</time_frame>
      <description>Recurrence rate of hydatid disease in patients</description>
    </secondary_outcome>
    <enrollment type="Actual">72</enrollment>
    <condition>Hydatid Cyst, Hepatic</condition>
    <eligibility>
      <study_pop>
        <textblock>
          We have analyzed 72 patients diagnosed with liver hydatid disease for a period of 10 years&#xD;
          from January 2006 until January 2017 treated surgically by cyst extraction, pericystectomy,&#xD;
          and omentopexy.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  hydatid liver disease&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  hydatid disease present outside the liver&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Elena Zafirovikj, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>UHSD St. Naum Ohridski</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Elena Zafirovikj</name>
        <address>
          <city>Skopje</city>
          <zip>1000</zip>
          <country>North Macedonia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>North Macedonia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University Hospital for Surgical Diseases St. Naum Ohridsk i- Skopje</investigator_affiliation>
      <investigator_full_name>Elena Zafirovikj</investigator_full_name>
      <investigator_title>Dr.</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Echinococcosis</mesh_term>
      <mesh_term>Echinococcosis, Hepatic</mesh_term>
      <mesh_term>Liver Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05989516
  org study id: 001/0/2023
  nct id: NCT05989516
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to show that cyst extraction with pericyst reduction
        and omentopexy is a suitable treatment for liver hydatid disease caused by E.Granulossus with
        a low rate of complication and recurrence.
  observational model: Other
  time perspective: Retrospective
  measure: Post operative complications
  time frame: one month
  description: Listing of complications according to Clavien -Dindo classification
  measure: Recurrence rate
  time frame: 5 years
  description: Recurrence rate of hydatid disease in patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 99 Years
  last name: Elena Zafirovikj, MD
  role: Principal Investigator
  affiliation: UHSD St. Naum Ohridski
  facility: 
  country: North Macedonia
  responsible party type: Principal Investigator
  investigator affiliation: University Hospital for Surgical Diseases St. Naum Ohridsk i- Skopje
  investigator full name: Elena Zafirovikj
  investigator title: Dr.
  mesh term: Echinococcosis
  mesh term: Echinococcosis, Hepatic
  mesh term: Liver Diseases
  sharing ipd: Undecided