<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/NCT04450277</url>
  </required_header>
  <id_info>
    <org_study_id>2020/00660</org_study_id>
    <nct_id>NCT04450277</nct_id>
  </id_info>
  <brief_title>Delivery of Protocolised Emergency Surgical Care During COVID-19 Pandemic</brief_title>
  <official_title>Delivery of Protocolised Emergency Surgical Care During COVID-19 Pandemic Based on Case Series</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Khoo Teck Puat Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Khoo Teck Puat 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>
      Emergency general surgical care during the COVID-19 pandemic presents a unique set of&#xD;
      considerations and challenges. Patients presenting with acute surgical conditions and&#xD;
      concomitant COVID-19 infection have higher risk of mortality and morbidity. The investigators&#xD;
      present their experience with COVID-19 positive patients presenting with acute surgical&#xD;
      conditions and reviewed the implementation of a protocolized pathway to mitigate the impact&#xD;
      of COVID-19 infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All COVID-19 positive patients who presented to the acute general surgical service over a&#xD;
      2-month period were identified. Patient data including demographics, surgical diagnosis,&#xD;
      mortality, morbidity and hospital length of stay was collected. Based on the investigators'&#xD;
      early experience from the first patient, the investigators designed a protocolized&#xD;
      institutional pathway which incorporated the risk of COVID-19 infection and urgency of&#xD;
      operation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2020</start_date>
  <completion_date type="Actual">May 31, 2020</completion_date>
  <primary_completion_date type="Actual">May 31, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Month</target_duration>
  <primary_outcome>
    <measure>Surgical morbidity in patients with COVID-19 infection and general surgical conditions</measure>
    <time_frame>Follow up 1 month</time_frame>
  </primary_outcome>
  <enrollment type="Actual">15</enrollment>
  <condition>COVID-19</condition>
  <condition>Emergency Surgery</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Emergency surgery</intervention_name>
    <description>Emergency surgery vs conservative management</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A propsective review was performed of all patients with laboratory-confirmed COVID-19&#xD;
        infection who presented with acute general surgical conditions to Khoo Teck Puat Hospital&#xD;
        (KTPH), in the period of 1st April 2020 to 31st May 2020. KTPH is a 795-bed regional&#xD;
        general hospital in Singapore that serves approximately half a million people in the&#xD;
        northern part of the city state. A confirmed case of COVID-19 was defined by a positive&#xD;
        result on a reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay of a specimen&#xD;
        collected on a nasopharyngeal swab. Patients underwent testing on admission if identified&#xD;
        as high risk as per national guidelines, or upon developing respiratory symptoms during&#xD;
        inpatient stay.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with emergency surgical conditions and tested positive for COVID-19&#xD;
             infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Nil&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Khoo Teck Puat Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>768828</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 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>COVID-19</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share individual participant data due to personal data protection act</ipd_description>
  </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/NCT04450277
org study id: 2020/00660
nct id: NCT04450277
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Emergency general surgical care during the COVID-19 pandemic presents a unique set of
      considerations and challenges. Patients presenting with acute surgical conditions and
      concomitant COVID-19 infection have higher risk of mortality and morbidity. The investigators
      present their experience with COVID-19 positive patients presenting with acute surgical
      conditions and reviewed the implementation of a protocolized pathway to mitigate the impact
      of COVID-19 infection.
All COVID-19 positive patients who presented to the acute general surgical service over a
      2-month period were identified. Patient data including demographics, surgical diagnosis,
      mortality, morbidity and hospital length of stay was collected. Based on the investigators'
      early experience from the first patient, the investigators designed a protocolized
      institutional pathway which incorporated the risk of COVID-19 infection and urgency of
      operation.
observational model: Cohort
time perspective: Prospective
measure: Surgical morbidity in patients with COVID-19 infection and general surgical conditions
time frame: Follow up 1 month
intervention type: Procedure
intervention name: Emergency surgery
description: Emergency surgery vs conservative management
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Singapore
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Emergencies
sharing ipd: No
ipd description: No plan to share individual participant data due to personal data protection act