<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/NCT01698099</url>
  </required_header>
  <id_info>
    <org_study_id>APP001</org_study_id>
    <nct_id>NCT01698099</nct_id>
  </id_info>
  <brief_title>Diagnostic Accuracy of Serum Bilirubin in the Prediction of Perforated Appendicitis</brief_title>
  <official_title>Diagnostic Accuracy of Serum Bilirubin in the Prediction of Perforated Appendicitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Tuebingen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hyperbilirubinemia is reported to be a positive predictor in diagnosing perforated&#xD;
      appendicitis. Therefore we analysed the diagnostic accuracy of serum bilirubin in&#xD;
      discriminating between perforated and simple/no appendicitis.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      All consecutive patients undergoing appendectomy for suspected appendicitis from May 2009 to&#xD;
      August 2011 were analysed. Primary endpoint was the diagnostic accuracy of serum bilirubin&#xD;
      levels to detect perforated appendicitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2009</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">August 2011</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>Diagnostic accuracy of serum bilirubin</measure>
    <time_frame>24h within initial presentation with clinical symptoms</time_frame>
    <description>assessment of the diagnostic accuracy of hyperbilirubinemia (defined as serum bilirubin above 1.1 md/dl)</description>
  </primary_outcome>
  <enrollment type="Actual">500</enrollment>
  <condition>Appendicitis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients undergoing appendectomy for suspected appendicitis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients undergoing appendectomy for suspected appendicitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  preexisting liver disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sven Müller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Tuebingen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Departement of Visceral- and Transplant Surgery, University of Tuebingen</name>
      <address>
        <city>Tuebingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>September 27, 2012</last_update_submitted>
  <last_update_submitted_qc>September 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Tuebingen</investigator_affiliation>
    <investigator_full_name>Sven Mueller</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Appendicitis</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/NCT01698099
org study id: APP001
nct id: NCT01698099
lead sponsor: 
has dmc: No
Hyperbilirubinemia is reported to be a positive predictor in diagnosing perforated
      appendicitis. Therefore we analysed the diagnostic accuracy of serum bilirubin in
      discriminating between perforated and simple/no appendicitis.

      Methods:

      All consecutive patients undergoing appendectomy for suspected appendicitis from May 2009 to
      August 2011 were analysed. Primary endpoint was the diagnostic accuracy of serum bilirubin
      levels to detect perforated appendicitis.
observational model: Cohort
time perspective: Retrospective
measure: Diagnostic accuracy of serum bilirubin
time frame: 24h within initial presentation with clinical symptoms
description: assessment of the diagnostic accuracy of hyperbilirubinemia (defined as serum bilirubin above 1.1 md/dl)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 95 Years
healthy volunteers: No
last name: Sven Müller, MD
role: Principal Investigator
affiliation: University Hospital Tuebingen
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital Tuebingen
investigator full name: Sven Mueller
investigator title: Principal Investigator
mesh term: Appendicitis