<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/NCT02983409</url>
  </required_header>
  <id_info>
    <org_study_id>UstoneCT</org_study_id>
    <nct_id>NCT02983409</nct_id>
  </id_info>
  <brief_title>Analysis the Relationship Between the Abdomen CT and Outcomes in Acute Urinary Stone Patients</brief_title>
  <official_title>A Study of Analysis the Relationship Between the Findings of Abdominal Comptuted Tomography and the Clinical Outcomes in Acute Urinary Stone Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Konkuk University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Konkuk University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an observational study based on retrospectively collected data of ureter stone&#xD;
      patients between 2011 and 2014. Aim of study is to determine radiologic findings of&#xD;
      non-contrast abdominal computerized tomography as predicting clinical outcomes of suspect&#xD;
      ureter stone patients in emergency department (ED).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gennerally, non-contrast abdominal computerized tomography is a choice of diagnosis for a&#xD;
      ureter stone patient.There was no known well of efficacy of CT for predicting the outcomes in&#xD;
      ureter stone patient in ED.&#xD;
&#xD;
      Hypothesis of this study are some findings of non-contrast CT may be helpful to predict the&#xD;
      clinical outcomes of pain severity (multidose of painkiller), admission and revisit to ED&#xD;
      within 5 days after discharge. Investigators analyzed multiple variables including age, sex,&#xD;
      initial clinical findings, and various CT findings to assess their association with outcomes;&#xD;
      multidose of painkiller in ED, admission at ED and revisit to ED within 5 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Multiple-painkiller</measure>
    <time_frame>within 6 hours after the ED visit</time_frame>
    <description>Patient who take the over 2 painkiller medication because of serious pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Admission at ED</measure>
    <time_frame>within 24 hours after the ED visit</time_frame>
    <description>Patient who admitted at the ED</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Revisit to the hospital within 5 days</measure>
    <time_frame>within 5 days after the ED discharge</time_frame>
    <description>Patient who revisit the hospital within 5 days after the ED discharge</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">862</enrollment>
  <condition>Urinary Calculi</condition>
  <condition>Emergency Service, Hospital</condition>
  <arm_group>
    <arm_group_label>Pstone</arm_group_label>
    <description>Adult Patients (&gt; 18years) who were diagnosed as the urinary stone in the ED. All patients who visited the ED with compalin of acute pain, and urinary stone was idenfied by urinary CT in the ED.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Pstone</intervention_name>
    <description>A adult patients who were diagnosed as urinary stone by the urinary CT</description>
    <arm_group_label>Pstone</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A adult (&gt;18 years) patients who was diagnosed as ureter stone. They had no previous&#xD;
        history of ureter stone within recent 1 year. They should not have a uninary congenital or&#xD;
        acquired anomaly and chronic renal disease.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ED Patients&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Confirmed the ureter stone by Abdomen or Urinary CT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known a uninary congenital or acquired anomaly&#xD;
&#xD;
          -  combined other healthy preblem at the ED&#xD;
&#xD;
               -  infection, renal dysfunction et al&#xD;
&#xD;
          -  Known the chronic disease : Hypertension ,Diabetes, Tuberculosis, Malignance et al&#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>Sang O Park, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>1Department of Emergency Medicine, School of Medicine, Konkuk University, Konkuk University Medical Center</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>October 26, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>August 17, 2017</last_update_submitted>
  <last_update_submitted_qc>August 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Konkuk University Medical Center</investigator_affiliation>
    <investigator_full_name>Sang O, Park</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>computerized tomography</keyword>
  <keyword>Urinary Calculi</keyword>
  <keyword>Patient admission</keyword>
  <keyword>Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Calculi</mesh_term>
    <mesh_term>Urolithiasis</mesh_term>
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Calculi</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/NCT02983409
org study id: UstoneCT
nct id: NCT02983409
lead sponsor: 
has dmc: Yes
This is an observational study based on retrospectively collected data of ureter stone
      patients between 2011 and 2014. Aim of study is to determine radiologic findings of
      non-contrast abdominal computerized tomography as predicting clinical outcomes of suspect
      ureter stone patients in emergency department (ED).
Gennerally, non-contrast abdominal computerized tomography is a choice of diagnosis for a
      ureter stone patient.There was no known well of efficacy of CT for predicting the outcomes in
      ureter stone patient in ED.

      Hypothesis of this study are some findings of non-contrast CT may be helpful to predict the
      clinical outcomes of pain severity (multidose of painkiller), admission and revisit to ED
      within 5 days after discharge. Investigators analyzed multiple variables including age, sex,
      initial clinical findings, and various CT findings to assess their association with outcomes;
      multidose of painkiller in ED, admission at ED and revisit to ED within 5 days.
observational model: Case-Only
time perspective: Retrospective
measure: Multiple-painkiller
time frame: within 6 hours after the ED visit
description: Patient who take the over 2 painkiller medication because of serious pain.
measure: Admission at ED
time frame: within 24 hours after the ED visit
description: Patient who admitted at the ED
measure: Revisit to the hospital within 5 days
time frame: within 5 days after the ED discharge
description: Patient who revisit the hospital within 5 days after the ED discharge
arm group label: Pstone
description: Adult Patients (> 18years) who were diagnosed as the urinary stone in the ED. All patients who visited the ED with compalin of acute pain, and urinary stone was idenfied by urinary CT in the ED.
intervention type: Radiation
intervention name: Pstone
description: A adult patients who were diagnosed as urinary stone by the urinary CT
arm group label: Pstone
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sang O Park, Dr
role: Principal Investigator
affiliation: 1Department of Emergency Medicine, School of Medicine, Konkuk University, Konkuk University Medical Center
responsible party type: Principal Investigator
investigator affiliation: Konkuk University Medical Center
investigator full name: Sang O, Park
investigator title: Assistant Professor
mesh term: Urinary Calculi
mesh term: Urolithiasis
mesh term: Emergencies
mesh term: Calculi
sharing ipd: No