<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/NCT04488549</url>
  </required_header>
  <id_info>
    <org_study_id>Treviso</org_study_id>
    <nct_id>NCT04488549</nct_id>
  </id_info>
  <brief_title>Delayed Colorectal Cancer Care During Coronavirus Disease (COVID-19) Pandemic (DECOR-19)</brief_title>
  <acronym>DECOR-19</acronym>
  <official_title>DElayed COloRectal Cancer Care During Coronavirus Disease (COVID-19) Pandemic (DECOR-19)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Treviso Regional Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gaetano Gallo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gian Luca Di Tanna</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Treviso Regional Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To understand and analyse the global impact of COVID-19 on outpatient services, inpatient&#xD;
      care, elective surgery, and perioperative colorectal cancer care, a DElayed COloRectal cancer&#xD;
      surgery (DECOR-19) survey was conducted in collaboration with numerous international&#xD;
      colorectal societies with the objective of obtaining several learning points from the impact&#xD;
      of the COVID-19 outbreak on our colorectal cancer patients which will assist us in the&#xD;
      ongoing management of our colorectal cancer patients and to provide us safe oncological&#xD;
      pathways for future outbreaks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2020</start_date>
  <completion_date type="Actual">June 10, 2020</completion_date>
  <primary_completion_date type="Actual">June 10, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Predictive power of respondents' and hospitals' demographics on delaying colorectal cancer care across 6 geographical regions</measure>
    <time_frame>20 days</time_frame>
    <description>Respondents' and hospitals' demographics include: gender, country of origin, type of hospital (i.e. academic or not), type of unit (general surgery vs. colorectal), no. hospital beds, no. yearly surgeries for colon and rectal cancer, hospital preparedness to the emergency (i.e. fully or partially dedicated or not involved in COVID-19 care), readily availability of external facilities for colorectal cancer surgery, cancer care coordinator, personal protective equipment, status of elective surgery, no. elective colorectal cancer patients needing urgent surgery, any change in the original management plan, no. colorectal cancer patients refusing surgery or being COVID-19 + on surgery or becoming COVID-19 + post-operatively, no. staff members quarantined or relocated in COVID-19 units, MDT meeting suspension, any delay in endoscopy, radiology, oncology, surgery, histopathology.</description>
  </primary_outcome>
  <enrollment type="Actual">1051</enrollment>
  <condition>Colo-rectal Cancer</condition>
  <condition>Colon Cancer</condition>
  <condition>Rectal Cancer</condition>
  <condition>Oncology</condition>
  <condition>Surgery</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey</intervention_name>
    <description>International E-survey</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The survey link was sent to scientific societies of interest to coloproctologists and&#xD;
        disseminated to their members. Participation was entirely voluntary with no compensation&#xD;
        offered. Informed consent was obtained from all those agreeing to complete a survey. This&#xD;
        study was exempt from review board approval at authors' institutions.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Members of renowned scientific societies with an interest in coloproctology&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Treviso Regional Hospital</name>
      <address>
        <city>Treviso</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>July 25, 2020</last_update_submitted>
  <last_update_submitted_qc>July 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04488549
org study id: Treviso
nct id: NCT04488549
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To understand and analyse the global impact of COVID-19 on outpatient services, inpatient
      care, elective surgery, and perioperative colorectal cancer care, a DElayed COloRectal cancer
      surgery (DECOR-19) survey was conducted in collaboration with numerous international
      colorectal societies with the objective of obtaining several learning points from the impact
      of the COVID-19 outbreak on our colorectal cancer patients which will assist us in the
      ongoing management of our colorectal cancer patients and to provide us safe oncological
      pathways for future outbreaks.
observational model: Other
time perspective: Prospective
measure: Predictive power of respondents' and hospitals' demographics on delaying colorectal cancer care across 6 geographical regions
time frame: 20 days
description: Respondents' and hospitals' demographics include: gender, country of origin, type of hospital (i.e. academic or not), type of unit (general surgery vs. colorectal), no. hospital beds, no. yearly surgeries for colon and rectal cancer, hospital preparedness to the emergency (i.e. fully or partially dedicated or not involved in COVID-19 care), readily availability of external facilities for colorectal cancer surgery, cancer care coordinator, personal protective equipment, status of elective surgery, no. elective colorectal cancer patients needing urgent surgery, any change in the original management plan, no. colorectal cancer patients refusing surgery or being COVID-19 + on surgery or becoming COVID-19 + post-operatively, no. staff members quarantined or relocated in COVID-19 units, MDT meeting suspension, any delay in endoscopy, radiology, oncology, surgery, histopathology.
intervention type: Other
intervention name: Survey
description: International E-survey
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Rectal Neoplasms
sharing ipd: Undecided