<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/NCT02219698</url>
  </required_header>
  <id_info>
    <org_study_id>HUS-Dnro122-2014</org_study_id>
    <nct_id>NCT02219698</nct_id>
  </id_info>
  <brief_title>Symptomatic Treatment of Acute Uncomplicated Diverticulitis</brief_title>
  <official_title>Symptomatic Treatment of Acute Uncomplicated Diverticulitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helsinki University Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vatsatautien tutkimussäätiö - foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mary and Georg Ehrnroot's foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Finnish Surgical society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Martti I. Turunen Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Governmental competitive funds (EVO)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Helsinki University Central Hospital</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the safety and efficacy of symptomatic treatment&#xD;
      (i.e. without antimicrobial drugs) of acute uncomplicated diverticulitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complications of diverticulitis</measure>
    <time_frame>30 days from allocation</time_frame>
    <description>Incidence of complications of diverticulitis (abscess, free perforation, need for surgery)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay (days)</measure>
    <time_frame>At the end of the hospital stay, an expected average of 2 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of re-admissions</measure>
    <time_frame>30 days from discharge</time_frame>
    <description>Number patients re-admitted to hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence of diverticulitis</measure>
    <time_frame>10 years</time_frame>
    <description>Number of recurrent diverticulitis within follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>30 days from allocation</time_frame>
    <description>Number of patients deceased</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for elective sigmoid resection</measure>
    <time_frame>10 years</time_frame>
    <description>Number of patients that have undergone elective sigmoid resection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for emergency surgery for diverticulitis on another admission</measure>
    <time_frame>10 years</time_frame>
    <description>Number of patients requiring emergency surgery for diverticulitis on another admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Commencement of antimicrobial drug</measure>
    <time_frame>For the duration of hospital stay, an expected average of 2 days</time_frame>
    <description>Number of patients that have received antimicrobial drugs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late complication of diverticulitis</measure>
    <time_frame>10 years</time_frame>
    <description>Number of patients who develop late complications of diverticulitis e.g. fistula, stricture</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stoma rate</measure>
    <time_frame>10 years</time_frame>
    <description>Number of patients who receive a stoma</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">158</enrollment>
  <condition>Diverticulitis</condition>
  <arm_group>
    <arm_group_label>Symptomatic treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen</intervention_name>
    <arm_group_label>Symptomatic treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paracetamol</intervention_name>
    <arm_group_label>Symptomatic treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Computed tomography-diagnosed acute uncomplicated* diverticulitis&#xD;
&#xD;
               -  No abscess, fistula, obstruction and distant intra- or retroperitoneal air.&#xD;
                  Pericolic air allowed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Already commenced antimicrobial medication&#xD;
&#xD;
          -  Immunosuppression (e.g. diabetes, corticosteroid medication, immunosuppressive&#xD;
             medication, chemotherapy, chronic liver disease)&#xD;
&#xD;
          -  Suspicion of generalized peritonitis&#xD;
&#xD;
          -  Organ dysfunction&#xD;
&#xD;
          -  Another infection requiring antimicrobial medication&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Age &lt; 18 years or &gt; 90 years&#xD;
&#xD;
          -  Missing written consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Helsinki University Central Hospital</name>
      <address>
        <city>Helsinki</city>
        <zip>00029</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>July 30, 2015</last_update_submitted>
  <last_update_submitted_qc>July 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 31, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Helsinki University Central Hospital</investigator_affiliation>
    <investigator_full_name>Ville Sallinen</investigator_full_name>
    <investigator_title>M.D., Ph.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diverticulitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Ibuprofen</mesh_term>
  </intervention_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/NCT02219698
org study id: HUS-Dnro122-2014
nct id: NCT02219698
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
The purpose of this study is to determine the safety and efficacy of symptomatic treatment
      (i.e. without antimicrobial drugs) of acute uncomplicated diverticulitis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Complications of diverticulitis
time frame: 30 days from allocation
description: Incidence of complications of diverticulitis (abscess, free perforation, need for surgery)
measure: Length of hospital stay (days)
time frame: At the end of the hospital stay, an expected average of 2 days
measure: Rate of re-admissions
time frame: 30 days from discharge
description: Number patients re-admitted to hospital
measure: Recurrence of diverticulitis
time frame: 10 years
description: Number of recurrent diverticulitis within follow-up
measure: Mortality
time frame: 30 days from allocation
description: Number of patients deceased
measure: Need for elective sigmoid resection
time frame: 10 years
description: Number of patients that have undergone elective sigmoid resection
measure: Need for emergency surgery for diverticulitis on another admission
time frame: 10 years
description: Number of patients requiring emergency surgery for diverticulitis on another admission
measure: Commencement of antimicrobial drug
time frame: For the duration of hospital stay, an expected average of 2 days
description: Number of patients that have received antimicrobial drugs
measure: Late complication of diverticulitis
time frame: 10 years
description: Number of patients who develop late complications of diverticulitis e.g. fistula, stricture
measure: Stoma rate
time frame: 10 years
description: Number of patients who receive a stoma
arm group label: Symptomatic treatment
arm group type: Experimental
intervention type: Drug
intervention name: Ibuprofen
arm group label: Symptomatic treatment
intervention type: Drug
intervention name: Paracetamol
arm group label: Symptomatic treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Helsinki University Central Hospital
investigator full name: Ville Sallinen
investigator title: M.D., Ph.D.
mesh term: Diverticulitis
mesh term: Acetaminophen
mesh term: Ibuprofen