<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/NCT03284476</url>
  </required_header>
  <id_info>
    <org_study_id>RC12_0207 doublon</org_study_id>
    <nct_id>NCT03284476</nct_id>
  </id_info>
  <brief_title>Post Surgically Treated Peritonitis Complications</brief_title>
  <official_title>A Prospective Cohort of Patients Hospitalized in West French Intensive Care Units for Peritonitis Surgically Treated</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this observational study is to investigate the management and the&#xD;
      complications associated wtih surgically treated peritonitis.&#xD;
&#xD;
      Data will be analysed to answer pre-defined scientific projects and to improve management of&#xD;
      these conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anonymous data will be collected by study coordinators in a secured e-database. Cross audit&#xD;
      will be performed to check data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No inclusion&#xD;
  </why_stopped>
  <start_date type="Anticipated">April 2013</start_date>
  <completion_date type="Actual">June 2020</completion_date>
  <primary_completion_date type="Actual">June 2020</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>In ICU stay main complications</measure>
    <time_frame>Within the first 28 days after ICU admission date</time_frame>
    <description>Nosocomial Infections (epidemiology, risk factors, antibiotic susceptibility of pathogens) Organ failures (incidence, risk factors)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of mechanical ventilation</measure>
    <time_frame>In ICU (up to 90 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>In ICU (up to 90 days)</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Death</measure>
    <time_frame>In ICU (up to 90 days)</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Peritonitis</condition>
  <arm_group>
    <arm_group_label>ICU patients</arm_group_label>
    <description>Collection of medical data of Patients with peritonitis (nosocomial or community-acquired) or Patients with post-operative peritonitis</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Collection of medical data from ICU patients</intervention_name>
    <description>Medical data collected on a electronic secured data base</description>
    <arm_group_label>ICU patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients hospitalized in ICU for peritonitis surgically treated&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nosocomial surgically treated Peritonitis&#xD;
&#xD;
          -  Or Community-Acquired surgically treated Peritonitis&#xD;
&#xD;
          -  Or Post-operative surgically treated Peritonitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Consent withdrawal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karim Asehnoune, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Non Affiliated</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Angers University Hospital</name>
      <address>
        <city>Angers</city>
        <zip>49000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nantes University Hospital</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Poitiers University Hospital</name>
      <address>
        <city>Poitiers</city>
        <zip>86000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rennes University Hospital</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tours University Hospital</name>
      <address>
        <city>Tours</city>
        <zip>37000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>June 2, 2020</last_update_submitted>
  <last_update_submitted_qc>June 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nosocomial Peritonitis</keyword>
  <keyword>Community-acquired Peritonitis</keyword>
  <keyword>Post-operative Peritonitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peritonitis</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/NCT03284476
org study id: RC12_0207 doublon
nct id: NCT03284476
lead sponsor: 
has dmc: No
The purpose of this observational study is to investigate the management and the
      complications associated wtih surgically treated peritonitis.

      Data will be analysed to answer pre-defined scientific projects and to improve management of
      these conditions.
Anonymous data will be collected by study coordinators in a secured e-database. Cross audit
      will be performed to check data.
observational model: Cohort
time perspective: Prospective
measure: In ICU stay main complications
time frame: Within the first 28 days after ICU admission date
description: Nosocomial Infections (epidemiology, risk factors, antibiotic susceptibility of pathogens) Organ failures (incidence, risk factors)
measure: Duration of mechanical ventilation
time frame: In ICU (up to 90 days)
measure: ICU length of stay
time frame: In ICU (up to 90 days)
measure: Death
time frame: In ICU (up to 90 days)
arm group label: ICU patients
description: Collection of medical data of Patients with peritonitis (nosocomial or community-acquired) or Patients with post-operative peritonitis
intervention type: Other
intervention name: Collection of medical data from ICU patients
description: Medical data collected on a electronic secured data base
arm group label: ICU patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: Karim Asehnoune, MD, PhD
role: Study Chair
affiliation: Non Affiliated
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Peritonitis