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/NCT06008535</url>
    </required_header>
    <id_info>
      <org_study_id>TartuUH_Surgery Clinic</org_study_id>
      <nct_id>NCT06008535</nct_id>
    </id_info>
    <brief_title>10-year Results of Open Inguinal Hernia Repair</brief_title>
    <official_title>10-year Results of Open Inguinal Hernia Repair. A Prospective Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tartu University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tartu University 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>
        The main goal of the research is to evaluate the long-term results of open anterior&#xD;
        alloplasty of inguinal hernia, mainly the occurrence of recurrences. The secondary aim of the&#xD;
        study is to clarify the incidence of chronic pain and foreign body sensation 10 years after&#xD;
        inguinal hernia surgery.&#xD;
  &#xD;
        Patients who meet the criteria for inclusion in the study are invited to an appointment,&#xD;
        where a questionnaire is filled out, an clinical examination and an ultrasound examination&#xD;
        are performed.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 22, 2018</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Recurrence</measure>
      <time_frame>at 10-year follow-up</time_frame>
      <description>Inguinal hernia recurrence on clinical examination or in ultrasound</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Chronic pain</measure>
      <time_frame>at 10-year follow-up</time_frame>
      <description>Chronic pain after open inguinal hernia repair. The pain questionnaire includes questions about pain at rest, on coughing, when rising from lying to sitting position and during physical effort and exercise (yes-or-no questions). If the answer to these questions are positive, then the pain is measured on visual analogue scale.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">420</enrollment>
    <condition>Recurrence</condition>
    <condition>Chronic Pain</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Open inguinal hernia repair</intervention_name>
      <description>Lichtenstein hernioplasty or open inguinal hernia repair with self-gripping mesh</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study group consists of patients who were operated on with a primary inguinal hernia in&#xD;
          the department of general surgery and plastic surgery between 2008-2013 at the Tartu&#xD;
          University Hospital.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  primary inguinal hernia operated between 2008-2013 at the Tartu University Hospital&#xD;
  &#xD;
            -  elective surgery&#xD;
  &#xD;
            -  age at least 18 years old at the time of the operation&#xD;
  &#xD;
            -  ability to understand the guidelines and willing to participate in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  recurrent hernia&#xD;
  &#xD;
            -  strangulated hernia&#xD;
  &#xD;
            -  age under 18 years at the time of surgery&#xD;
  &#xD;
            -  does not agree to participate in the study&#xD;
  &#xD;
            -  does not understand the guidelines. Regarding the last exclusion criterion: since it&#xD;
               is an assessment of the remote results of the treatment and probably relatively many&#xD;
               of the subjects are very elderly, it may happen that when contacting the patient by&#xD;
               phone it turns out that the patient is no longer adequate to make a decision about&#xD;
               participating in the study or to answer questions (experienced cerebral infarction,&#xD;
               dementia, etc. .) - in this case, the patient is not invited to the appointment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ceith Nikkolo, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Tartu University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ceith Nikkolo, PhD</last_name>
      <phone>+37253319082</phone>
      <email>ceith.nikkolo@kliinikum.ee</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Urmas Lepner, PhD</last_name>
      <phone>+3727318201</phone>
      <email>urmas.lepner@kliinikum.ee</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Tartu University Hospital</name>
        <address>
          <city>Tartu</city>
          <state>Tartumaa</state>
          <zip>50406</zip>
          <country>Estonia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ceith Nikkolo, PhD</last_name>
        <phone>+37253319082</phone>
        <email>ceith.nikkolo@kliinikum.ee</email>
      </contact>
      <contact_backup>
        <last_name>Urmas Lepner, PhD</last_name>
        <phone>+3727318201</phone>
        <email>urmas.lepner@kliinikum.ee</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Estonia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tartu University Hospital</investigator_affiliation>
      <investigator_full_name>Ceith Nikkolo</investigator_full_name>
      <investigator_title>general surgeon</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Chronic Pain</mesh_term>
      <mesh_term>Recurrence</mesh_term>
      <mesh_term>Hernia, Inguinal</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/NCT06008535
  org study id: TartuUH_Surgery Clinic
  nct id: NCT06008535
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The main goal of the research is to evaluate the long-term results of open anterior
        alloplasty of inguinal hernia, mainly the occurrence of recurrences. The secondary aim of the
        study is to clarify the incidence of chronic pain and foreign body sensation 10 years after
        inguinal hernia surgery.
  
        Patients who meet the criteria for inclusion in the study are invited to an appointment,
        where a questionnaire is filled out, an clinical examination and an ultrasound examination
        are performed.
  observational model: Case-Only
  time perspective: Prospective
  measure: Recurrence
  time frame: at 10-year follow-up
  description: Inguinal hernia recurrence on clinical examination or in ultrasound
  measure: Chronic pain
  time frame: at 10-year follow-up
  description: Chronic pain after open inguinal hernia repair. The pain questionnaire includes questions about pain at rest, on coughing, when rising from lying to sitting position and during physical effort and exercise (yes-or-no questions). If the answer to these questions are positive, then the pain is measured on visual analogue scale.
  intervention type: Procedure
  intervention name: Open inguinal hernia repair
  description: Lichtenstein hernioplasty or open inguinal hernia repair with self-gripping mesh
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ceith Nikkolo, PhD
  role: Principal Investigator
  affiliation: Tartu University Hospital
  last name: Ceith Nikkolo, PhD
  phone: +37253319082
  email: ceith.nikkolo@kliinikum.ee
  last name: Urmas Lepner, PhD
  phone: +3727318201
  email: urmas.lepner@kliinikum.ee
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Estonia
  responsible party type: Principal Investigator
  investigator affiliation: Tartu University Hospital
  investigator full name: Ceith Nikkolo
  investigator title: general surgeon
  mesh term: Chronic Pain
  mesh term: Recurrence
  mesh term: Hernia, Inguinal
  sharing ipd: Undecided