<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/NCT04449783</url>
  </required_header>
  <id_info>
    <org_study_id>SP0355</org_study_id>
    <nct_id>NCT04449783</nct_id>
  </id_info>
  <brief_title>Preoperative Shielding and N/T RT-PCR Swabbing for Elective Cancer Surgery</brief_title>
  <acronym>CHICANE</acronym>
  <official_title>A Cohort Study to Assess the Effectiveness of Preoperative Shielding and N/T RT-PCR Swabbing for Elective Cancer Surgery Patients in the COVID-19 Pandemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Liverpool University Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Liverpool University Hospitals NHS Foundation Trust</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>
      trial to assess the effectiveness of pre-operative screening for COVID-19 in patients&#xD;
      undergoing elective cancer surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Background:&#xD;
&#xD;
           The optimal method of screening patients for COVID infection before elective cancer&#xD;
           surgery is unclear. Provisional data from the international COVIDsurg audit as well as a&#xD;
           similar study from China has shown mortality rates of in excess of 20% for COVID +ve&#xD;
           patients undergoing surgery and so ensuring patients do not have infection before&#xD;
           surgery is critical (1).&#xD;
&#xD;
           Current practice for the preoperative screening of elective surgical patients involves a&#xD;
           period of self-isolation, assessment of self-reported symptoms and nose and throat swab&#xD;
           testing. Many patients are asymptomatic with COVID and the false negative rate of RT-PCR&#xD;
           nose and throat swabs may be as high as 30% (2,3). Furthermore, we do not know how&#xD;
           effective our strategy is at preventing hospital acquired COVID in the days after&#xD;
           surgery. Patients are currently going to designated clean (silver) wards postoperatively&#xD;
           to reduce this risk with other patient who have tested negatively to the above screening&#xD;
           process too&#xD;
&#xD;
        2. Rationale:&#xD;
&#xD;
      The aim of this study is to assess the rate of perioperative COVID in elective surgical&#xD;
      patients, and to assess whether RT-PCR swabbing adds any additional value i.e. does it detect&#xD;
      clinically important asymptomatic patients.&#xD;
&#xD;
      If asymptomatic patients are diagnosed preoperatively this will reduce perioperative&#xD;
      morbidity and mortality as well as confirming this as an appropriate preoperative screening&#xD;
      process. Alternatively, should nose and throat swabbing not improve the diagnosis of COVID-19&#xD;
      in asymptomatic patients this trial may stop unnecessary visit to the hospital where they may&#xD;
      be more likely to contract COVID-19 and reduce the use of a limited resource.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 25, 2020</start_date>
  <completion_date type="Anticipated">September 25, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 25, 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>diagnosis of COVID before surgery</measure>
    <time_frame>prior to surgery</time_frame>
    <description>Diagnosis of COVID on day of surgery (based on Clinical symptoms +/- positive swab diagnosis)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>diagnosis of COVID after surgery</measure>
    <time_frame>14 days post op</time_frame>
    <description>Diagnosis by day 14 (+/-2) post-surgery (based on Clinical symptoms from inpatient notes or telephone consultation +/- positive swab diagnosis)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Covid19</condition>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>study patients</arm_group_label>
    <description>Patients undergoing elective cancer surgery, who will receive pre-operative screening including reporting symptoms and nose and throat swabbing 48 hours prior to surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>pre-operative screening</intervention_name>
    <description>reported symptoms plus nose and throat swabbing 48 hrs prior to surgery</description>
    <arm_group_label>study patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>telephone consult</intervention_name>
    <description>telephone consult 14 days (+/- 2 days) to assess for any COVID-19 symptoms</description>
    <arm_group_label>study patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All adult patients undergoing elective cancer surgery with an inpatient stay&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  participants capable of giving informed consent,&#xD;
&#xD;
          -  gender: Male and Female&#xD;
&#xD;
          -  Age: 18 years and above&#xD;
&#xD;
          -  Preoperative cancer patients (elective)&#xD;
&#xD;
          -  Willing to be contacted by phone after hospital discharge&#xD;
&#xD;
          -  Patients listed for inpatient admission postoperatively (cancer patients)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cancer patients who require non-cancer surgery&#xD;
&#xD;
          -  emergency cancer operations&#xD;
&#xD;
          -  Patients under the age of 18&#xD;
&#xD;
          -  Patients who do not have capacity to consent&#xD;
&#xD;
          -  Cancer patients not requiring an inpatient stay postoperatively&#xD;
&#xD;
          -  Patients who it was not anticipated would require an inpatient stay preoperatively but&#xD;
             required admission after surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Robert Jones, MBChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Liverpool University Hospitals NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Robert Jones, MBChB</last_name>
    <phone>0151 525 5980</phone>
    <email>robert.jones@liverpool.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Peter Gaskell, MBChB</last_name>
    <phone>0151 525 5980</phone>
    <email>p.gaskell@doctors.org.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Liverpool University Hospitals NHS Foundation Trust</name>
      <address>
        <city>Liverpool</city>
        <state>Merseyside</state>
        <zip>L9 7AL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert Jones, MBChB</last_name>
      <phone>0151 525 5980</phone>
      <email>robert.jones@liverpool.ac.uk</email>
    </contact>
    <investigator>
      <last_name>Robert Jones, MBChB</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Peter Gaskell, MBChB</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Terry Jones, MBBS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>will not be shared</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/NCT04449783
org study id: SP0355
nct id: NCT04449783
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
trial to assess the effectiveness of pre-operative screening for COVID-19 in patients
      undergoing elective cancer surgery.
1. Background:

           The optimal method of screening patients for COVID infection before elective cancer
           surgery is unclear. Provisional data from the international COVIDsurg audit as well as a
           similar study from China has shown mortality rates of in excess of 20% for COVID +ve
           patients undergoing surgery and so ensuring patients do not have infection before
           surgery is critical (1).

           Current practice for the preoperative screening of elective surgical patients involves a
           period of self-isolation, assessment of self-reported symptoms and nose and throat swab
           testing. Many patients are asymptomatic with COVID and the false negative rate of RT-PCR
           nose and throat swabs may be as high as 30% (2,3). Furthermore, we do not know how
           effective our strategy is at preventing hospital acquired COVID in the days after
           surgery. Patients are currently going to designated clean (silver) wards postoperatively
           to reduce this risk with other patient who have tested negatively to the above screening
           process too

        2. Rationale:

      The aim of this study is to assess the rate of perioperative COVID in elective surgical
      patients, and to assess whether RT-PCR swabbing adds any additional value i.e. does it detect
      clinically important asymptomatic patients.

      If asymptomatic patients are diagnosed preoperatively this will reduce perioperative
      morbidity and mortality as well as confirming this as an appropriate preoperative screening
      process. Alternatively, should nose and throat swabbing not improve the diagnosis of COVID-19
      in asymptomatic patients this trial may stop unnecessary visit to the hospital where they may
      be more likely to contract COVID-19 and reduce the use of a limited resource.
observational model: Cohort
time perspective: Prospective
measure: diagnosis of COVID before surgery
time frame: prior to surgery
description: Diagnosis of COVID on day of surgery (based on Clinical symptoms +/- positive swab diagnosis)
measure: diagnosis of COVID after surgery
time frame: 14 days post op
description: Diagnosis by day 14 (+/-2) post-surgery (based on Clinical symptoms from inpatient notes or telephone consultation +/- positive swab diagnosis)
arm group label: study patients
description: Patients undergoing elective cancer surgery, who will receive pre-operative screening including reporting symptoms and nose and throat swabbing 48 hours prior to surgery
intervention type: Other
intervention name: pre-operative screening
description: reported symptoms plus nose and throat swabbing 48 hrs prior to surgery
arm group label: study patients
intervention type: Other
intervention name: telephone consult
description: telephone consult 14 days (+/- 2 days) to assess for any COVID-19 symptoms
arm group label: study patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Robert Jones, MBChB
role: Principal Investigator
affiliation: Liverpool University Hospitals NHS Foundation Trust
last name: Robert Jones, MBChB
phone: 0151 525 5980
email: robert.jones@liverpool.ac.uk
last name: Peter Gaskell, MBChB
phone: 0151 525 5980
email: p.gaskell@doctors.org.uk
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No
ipd description: will not be shared