<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/NCT04430062</url>
  </required_header>
  <id_info>
    <org_study_id>Covid19nr1</org_study_id>
    <nct_id>NCT04430062</nct_id>
  </id_info>
  <brief_title>Short-term Outcome of Covid-19 Surgical Patients: Case-series of a High-risk Area Community Hospital</brief_title>
  <official_title>Short-term Outcome of Covid-19 Surgical Patients: Case-series of a High-risk Area Community Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Socio Sanitaria Territoriale di Lodi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Socio Sanitaria Territoriale di Lodi</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>
      The investigators retrospectively evaluated all the patients operated in a high-risk&#xD;
      community hospital from the first Italian case of Covid-19 (February 21st) to the April 10th&#xD;
      (in order to have at least a 30-days follow-up). The investigators selected those patients&#xD;
      who had a preoperative or post-operative positive Real Time - Polymerase Chain Reaction&#xD;
      (RT-PCR) for SARS-CoV-2 and the clinical outcome of the participants was evaluated in term of&#xD;
      need of Intensive Care Unit (ICU) post-operative recovery, medical and surgical&#xD;
      complications, length of hospital stay and death.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Actual">May 30, 2020</completion_date>
  <primary_completion_date type="Actual">May 20, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">14</enrollment>
  <condition>General Surgery</condition>
  <condition>Disease Outbreaks</condition>
  <arm_group>
    <arm_group_label>Covid-19 patients operated (February 21st -April 10th)</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical procedures performed under general anesthesia</intervention_name>
    <description>Surgical procedures performed under general anesthesia in patients with perioperative SARS-CoV-2 infection</description>
    <arm_group_label>Covid-19 patients operated (February 21st -April 10th)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        General population referring to a community hospital during the SARS-CoV-2 outbreak in the&#xD;
        Northern Italy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  preoperative or post-operative positive Real Time - Polymerase Chain Reaction (RT-PCR)&#xD;
             for SARS-CoV-2&#xD;
&#xD;
          -  surgical procedure in elective or acute care surgery performed under general&#xD;
             anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients operated without general anesthesia&#xD;
&#xD;
          -  patients preoperatively intubated for Covid-19&#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>Ospedale di Lodi - ASST Lodi</name>
      <address>
        <city>Lodi</city>
        <state>Lombardia</state>
        <zip>26900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Socio Sanitaria Territoriale di Lodi</investigator_affiliation>
    <investigator_full_name>Michele Ballabio</investigator_full_name>
    <investigator_title>Michele Ballabio, MD, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Surgery</keyword>
  <keyword>Covid-19</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>Surgical outcome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04430062
org study id: Covid19nr1
nct id: NCT04430062
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators retrospectively evaluated all the patients operated in a high-risk
      community hospital from the first Italian case of Covid-19 (February 21st) to the April 10th
      (in order to have at least a 30-days follow-up). The investigators selected those patients
      who had a preoperative or post-operative positive Real Time - Polymerase Chain Reaction
      (RT-PCR) for SARS-CoV-2 and the clinical outcome of the participants was evaluated in term of
      need of Intensive Care Unit (ICU) post-operative recovery, medical and surgical
      complications, length of hospital stay and death.
observational model: Case-Only
time perspective: Retrospective
measure: Mortality
time frame: 30 days
arm group label: Covid-19 patients operated (February 21st -April 10th)
intervention type: Procedure
intervention name: Surgical procedures performed under general anesthesia
description: Surgical procedures performed under general anesthesia in patients with perioperative SARS-CoV-2 infection
arm group label: Covid-19 patients operated (February 21st -April 10th)
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: Principal Investigator
investigator affiliation: Azienda Socio Sanitaria Territoriale di Lodi
investigator full name: Michele Ballabio
investigator title: Michele Ballabio, MD, Principal Investigator
mesh term: COVID-19
mesh term: Anesthetics
sharing ipd: No