<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/NCT01718171</url>
  </required_header>
  <id_info>
    <org_study_id>HLS-0044-2012</org_study_id>
    <nct_id>NCT01718171</nct_id>
  </id_info>
  <brief_title>Inflammatory Response in Appendicitis</brief_title>
  <official_title>Progression of the Systemic Inflammatory Response in Patients With Appendicitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cirujanos la Serena</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cirujanos la Serena</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Although the presence of SIRS has been described in patients with appendicitis, its&#xD;
      progressive response related and together with progression of symptomatology from the onset&#xD;
      of symptoms to diagnostic has not been characterized. Continuation of the systemic&#xD;
      inflammation in patients with injury and infectious processes may result in multiple organ&#xD;
      dysfunction and ultimately failure. As with any acute inflammatory condition, the patients'&#xD;
      systemic inflammatory response to appendicitis will progress and become more intense with the&#xD;
      passing of time. The purpose of this study is to characterize the systemic inflammatory&#xD;
      response to appendicitis from the beginning of symptoms to diagnostic in patients with&#xD;
      appendicitis submitted to emergency surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  A prospective non-interventional, observational, descriptive study was conducted.&#xD;
&#xD;
        -  At our institution a median of 250 adult patients are submitted to emergency&#xD;
           appendectomy every year. From this universe, a sample of 152 patients with a power of&#xD;
           80%, an error of 5% and 95% Confidence Intervals was required to perform this study.&#xD;
&#xD;
        -  We included 268 patients in the database, of them 85 cases that did not comply with the&#xD;
           inclusion criteria were excluded from the analysis. A total of 183 patients (100%)&#xD;
           selected according to the following criteria were studied: Patients with appendicitis&#xD;
           confirmed by histology operated on our institutional Emergency Unit with an age range&#xD;
           from 15 to 80 years.&#xD;
&#xD;
        -  Any patient with immunosuppressive or immunodeppressive known pathological conditions&#xD;
           was excluded, as well as any patient with a pathological report describing a normal&#xD;
           appendix.&#xD;
&#xD;
        -  Patients were divided into four groups according to the interval of time calculated from&#xD;
           the onset of symptoms to diagnostic: Group I from 0 to 24 h, Group II from 25 to 48 h,&#xD;
           Group III from 49 to 72 h and Group IV more than 73 h.&#xD;
&#xD;
        -  At admission demographic, clinical data, and the interval of time from the onset of&#xD;
           symptoms to diagnostic was recorded, together with the White Blood Cell (WBC) count,&#xD;
           C-reactive protein (CRP) values, and SIRS score.&#xD;
&#xD;
        -  The primary outcome measure was to determine the expected systemic inflammatory response&#xD;
           to acute appendicitis according to established groups of time intervals from the onset&#xD;
           of symptoms to diagnostic using the SIRS for that purpose.&#xD;
&#xD;
        -  The secondary outcome measure was the analysis of the CRP to measure the systemic&#xD;
           inflammatory response, as another parameter which is habitually included within the&#xD;
           diagnostic study of patients with suspected appendicitis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">January 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>THE EXPECTED SYSTEMIC INFLAMMATORY RESPONSE TO APPENDICITIS</measure>
    <time_frame>0 to more than 72 hours</time_frame>
    <description>Four groups of time intervals divided as follows:&#xD;
Group I: 0 - 24 hours Group II: 25 - 48 hours Group III: 49 - 72 hours Group IV: More than 73 hours</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>THE ANALYSIS OF C REACTIVE PROTEIN TO MEASURE THE SYSTEMIC INFLAMMATORY RESPONSE TO APPENDICITIS</measure>
    <time_frame>from 0 to more than 72 hours</time_frame>
    <description>Measurements of C-reactive protein levels</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">183</enrollment>
  <condition>Appendicitis</condition>
  <arm_group>
    <arm_group_label>Group I, Group II, Group III, Group IV</arm_group_label>
    <description>Values and results of the Systemic Inflammatory Response and C-reactive protein to appendicitis</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with appendicitis operated on and confirmed with biopsy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with appendicitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any patient with immunosuppressive or immunodeppressive known pathological conditions&#xD;
&#xD;
          -  Any patient with a pathological report describing a normal appendix&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcelo A Beltran, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>La Serena Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de La Serena (La Serena Hospital)</name>
      <address>
        <city>La Serena</city>
        <state>IV Region</state>
        <zip>17000000</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>October 29, 2012</last_update_submitted>
  <last_update_submitted_qc>October 29, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 31, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cirujanos la Serena</investigator_affiliation>
    <investigator_full_name>MARCELO A. BELTRAN, M.D.</investigator_full_name>
    <investigator_title>DIGESTIVE SURGEON</investigator_title>
  </responsible_party>
  <keyword>Appendicitis</keyword>
  <keyword>SIRS</keyword>
  <keyword>C-reactive protein</keyword>
  <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/NCT01718171
org study id: HLS-0044-2012
nct id: NCT01718171
lead sponsor: 
has dmc: No
Although the presence of SIRS has been described in patients with appendicitis, its
      progressive response related and together with progression of symptomatology from the onset
      of symptoms to diagnostic has not been characterized. Continuation of the systemic
      inflammation in patients with injury and infectious processes may result in multiple organ
      dysfunction and ultimately failure. As with any acute inflammatory condition, the patients'
      systemic inflammatory response to appendicitis will progress and become more intense with the
      passing of time. The purpose of this study is to characterize the systemic inflammatory
      response to appendicitis from the beginning of symptoms to diagnostic in patients with
      appendicitis submitted to emergency surgery.
-  A prospective non-interventional, observational, descriptive study was conducted.

        -  At our institution a median of 250 adult patients are submitted to emergency
           appendectomy every year. From this universe, a sample of 152 patients with a power of
           80%, an error of 5% and 95% Confidence Intervals was required to perform this study.

        -  We included 268 patients in the database, of them 85 cases that did not comply with the
           inclusion criteria were excluded from the analysis. A total of 183 patients (100%)
           selected according to the following criteria were studied: Patients with appendicitis
           confirmed by histology operated on our institutional Emergency Unit with an age range
           from 15 to 80 years.

        -  Any patient with immunosuppressive or immunodeppressive known pathological conditions
           was excluded, as well as any patient with a pathological report describing a normal
           appendix.

        -  Patients were divided into four groups according to the interval of time calculated from
           the onset of symptoms to diagnostic: Group I from 0 to 24 h, Group II from 25 to 48 h,
           Group III from 49 to 72 h and Group IV more than 73 h.

        -  At admission demographic, clinical data, and the interval of time from the onset of
           symptoms to diagnostic was recorded, together with the White Blood Cell (WBC) count,
           C-reactive protein (CRP) values, and SIRS score.

        -  The primary outcome measure was to determine the expected systemic inflammatory response
           to acute appendicitis according to established groups of time intervals from the onset
           of symptoms to diagnostic using the SIRS for that purpose.

        -  The secondary outcome measure was the analysis of the CRP to measure the systemic
           inflammatory response, as another parameter which is habitually included within the
           diagnostic study of patients with suspected appendicitis.
observational model: Case-Control
time perspective: Prospective
measure: THE EXPECTED SYSTEMIC INFLAMMATORY RESPONSE TO APPENDICITIS
time frame: 0 to more than 72 hours
description: Four groups of time intervals divided as follows:
Group I: 0 - 24 hours Group II: 25 - 48 hours Group III: 49 - 72 hours Group IV: More than 73 hours
measure: THE ANALYSIS OF C REACTIVE PROTEIN TO MEASURE THE SYSTEMIC INFLAMMATORY RESPONSE TO APPENDICITIS
time frame: from 0 to more than 72 hours
description: Measurements of C-reactive protein levels
arm group label: Group I, Group II, Group III, Group IV
description: Values and results of the Systemic Inflammatory Response and C-reactive protein to appendicitis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 80 Years
healthy volunteers: No
last name: Marcelo A Beltran, M.D.
role: Principal Investigator
affiliation: La Serena Hospital
facility: 
country: Chile
responsible party type: Principal Investigator
investigator affiliation: Cirujanos la Serena
investigator full name: MARCELO A. BELTRAN, M.D.
investigator title: DIGESTIVE SURGEON
mesh term: Appendicitis