<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/NCT04401124</url>
  </required_header>
  <id_info>
    <org_study_id>BFH-SurgeryCovid</org_study_id>
    <nct_id>NCT04401124</nct_id>
  </id_info>
  <brief_title>Status of Management of Surgery in Beijing During COVID-19</brief_title>
  <official_title>A Descriptive Study on the Proper Management of Gastrointestinal Surgeries During the COVID-19 Pandemic, With an Emphasis on the Alteration of Surgical Protocol and Workflow</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xuanwu Hospital, Beijing</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Chao Yang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University Cancer Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>China-Japan Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University Shougang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Friendship Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a multi-centered, retrospective, observational study aimed at observing the current&#xD;
      status of the management of gastrointestinal surgery during the COVID-19 pandemic,&#xD;
      particularly the changes on surgery protocols and other key aspects of surgical workflow, so&#xD;
      as to share experience with colleagues both domestic and abroad.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">May 25, 2020</start_date>
  <completion_date type="Anticipated">June 7, 2020</completion_date>
  <primary_completion_date type="Anticipated">May 31, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>treatment of fevers at arrival</measure>
    <time_frame>1 day</time_frame>
    <description>proportion of patients presented with fever, proportion of patients refered to fever clinics, proportion of patients screened for COVID-19, method of screening (CT? nucleated acid test?)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>treatment of post-operative fevers</measure>
    <time_frame>1 day</time_frame>
    <description>proportion of patients on whom fever occured, proportion of patients screened for COVID-19, method of screening (CT? nucleated acid test?)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>assorted surgical parameters</measure>
    <time_frame>1 day</time_frame>
    <description>Duration of operation (≥180min/&lt;180min); Intra-operative transfusion (Y/N); Surgical approach (Laparoscopy-involved/Open); Resection range (Non-radical/Radical); Lymph node dissection (Unknown/Not dissected/D1/D2 or above); Combined organ resection (Y/N); Post-operative complications (Y/N); Post-operative transfusion (Y/N); Post-operative hospital stay (≥7d/&lt;7d)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>hospitals' protection measures and extent of implementation</measure>
    <time_frame>1 month</time_frame>
    <description>Out-patient of surgery (Open/Closed); Emergency of surgery (Open/Closed); Fever clinic (Open/Closed); Surgical ward (Open/Closed); Functional level of surgical ward (Receive emergency surgery patients only/Receive surgery patients only/Receive all kinds of patients); Isolation ward for suspected COVID-19 patients (With/Without); Bed number in each surgical ward room (1/2/≥3); Isolation area within surgical ward (With/Without); Usage of sub-pressure operation theaters (Routinely applied/Applied for suspected patients/Never applied); Protection level of surgeons in surgical ward (No specific protection/Regular medical masks/Any of N95 mask, eye/face shields, gowns); Protection level of surgeons in ER room (No specific protection/Regular medical masks/Any of N95 mask, eye shields, face shields, gowns)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Gastric Cancer</condition>
  <condition>Colorectal Cancer</condition>
  <condition>Gastrointestinal Disease</condition>
  <arm_group>
    <arm_group_label>patients treated at surgical emergency rooms</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>patients receiving surgeries (both elected and emergency)</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention</intervention_name>
    <description>no intervention</description>
    <arm_group_label>patients receiving surgeries (both elected and emergency)</arm_group_label>
    <arm_group_label>patients treated at surgical emergency rooms</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients at surgical ER, and patients in gastrointestinal wards&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients arriving at surgical emergency and all patients receiving&#xD;
             gastrointestinal surgeries in participating centers from 2020.1.1~2020.3.31.&#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>
  <overall_official>
    <last_name>Zhongtao Zhang, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Friendship Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kai Pang, M.D.</last_name>
    <phone>18811792819</phone>
    <phone_ext>18811792819</phone_ext>
    <email>pang_kai@ccmu.edu.cn</email>
  </overall_contact>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Friendship Hospital</investigator_affiliation>
    <investigator_full_name>Zhongtao Zhang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Diseases</mesh_term>
    <mesh_term>Digestive System Diseases</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/NCT04401124
org study id: BFH-SurgeryCovid
nct id: NCT04401124
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a multi-centered, retrospective, observational study aimed at observing the current
      status of the management of gastrointestinal surgery during the COVID-19 pandemic,
      particularly the changes on surgery protocols and other key aspects of surgical workflow, so
      as to share experience with colleagues both domestic and abroad.
observational model: Cohort
time perspective: Retrospective
measure: treatment of fevers at arrival
time frame: 1 day
description: proportion of patients presented with fever, proportion of patients refered to fever clinics, proportion of patients screened for COVID-19, method of screening (CT? nucleated acid test?)
measure: treatment of post-operative fevers
time frame: 1 day
description: proportion of patients on whom fever occured, proportion of patients screened for COVID-19, method of screening (CT? nucleated acid test?)
measure: assorted surgical parameters
time frame: 1 day
description: Duration of operation (≥180min/<180min); Intra-operative transfusion (Y/N); Surgical approach (Laparoscopy-involved/Open); Resection range (Non-radical/Radical); Lymph node dissection (Unknown/Not dissected/D1/D2 or above); Combined organ resection (Y/N); Post-operative complications (Y/N); Post-operative transfusion (Y/N); Post-operative hospital stay (≥7d/<7d)
measure: hospitals' protection measures and extent of implementation
time frame: 1 month
description: Out-patient of surgery (Open/Closed); Emergency of surgery (Open/Closed); Fever clinic (Open/Closed); Surgical ward (Open/Closed); Functional level of surgical ward (Receive emergency surgery patients only/Receive surgery patients only/Receive all kinds of patients); Isolation ward for suspected COVID-19 patients (With/Without); Bed number in each surgical ward room (1/2/≥3); Isolation area within surgical ward (With/Without); Usage of sub-pressure operation theaters (Routinely applied/Applied for suspected patients/Never applied); Protection level of surgeons in surgical ward (No specific protection/Regular medical masks/Any of N95 mask, eye/face shields, gowns); Protection level of surgeons in ER room (No specific protection/Regular medical masks/Any of N95 mask, eye shields, face shields, gowns)
arm group label: patients treated at surgical emergency rooms
arm group label: patients receiving surgeries (both elected and emergency)
intervention type: Other
intervention name: no intervention
description: no intervention
arm group label: patients receiving surgeries (both elected and emergency)
arm group label: patients treated at surgical emergency rooms
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Zhongtao Zhang, M.D.
role: Principal Investigator
affiliation: Beijing Friendship Hospital
last name: Kai Pang, M.D.
phone: 18811792819
phone ext: 18811792819
email: pang_kai@ccmu.edu.cn
responsible party type: Principal Investigator
investigator affiliation: Beijing Friendship Hospital
investigator full name: Zhongtao Zhang
investigator title: Professor
mesh term: Gastrointestinal Diseases
mesh term: Digestive System Diseases
sharing ipd: Undecided