<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/NCT04419571</url>
  </required_header>
  <id_info>
    <org_study_id>133196</org_study_id>
    <nct_id>NCT04419571</nct_id>
  </id_info>
  <brief_title>Outcomes in Emergency Laparotomies During COVID-19 Pandemic</brief_title>
  <official_title>Emergency Laparotomies and Outcomes During the COVID-19 Pandemic - a Retrospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Barking, Havering and Redbridge University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Barking, Havering and Redbridge University Hospitals NHS Trust</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      NLR has previously been observed to correlate with complications in upper GI (1) and&#xD;
      colorectal (2) surgery. The investigators sought to assess if a similar correlation can be&#xD;
      identified in emergency general surgical patients and if the presence of suspected or&#xD;
      confirmed COVID-19 may impact on this.&#xD;
&#xD;
      Given the heterogeneity of emergency general surgery the investigators therefore plan to&#xD;
      perform a retrospective review of patients having emergency laparotomies only at a single NHS&#xD;
      site during COVID-19 pandemic. Assessment of outcomes and Neutrophil:lymphocyte ratio as a&#xD;
      predictor of outcomes will be completed. Outcomes will be completed in line with the recent&#xD;
      COVIDSurg study criteria (3). The primary outcome is 30-day mortality. Secondary outcomes are&#xD;
      7-day mortality, re-operation, length of stay, post-operative respiratory failure,&#xD;
      post-operative ARDS (Acute Respiratory Distress Syndrome), post-operative sepsis and ITU&#xD;
      (Intensive Therapy Unit)/HDU (High Dependency Unit) admission.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 23, 2020</start_date>
  <completion_date type="Actual">June 16, 2020</completion_date>
  <primary_completion_date type="Actual">June 16, 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>30-day mortality</measure>
    <time_frame>30 days</time_frame>
    <description>Mortality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>7-day mortality</measure>
    <time_frame>7 days</time_frame>
    <description>Mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants returning to theatre</measure>
    <time_frame>30 days</time_frame>
    <description>Re-operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>30 days</time_frame>
    <description>Inpatient stay during index admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative respiratory failure</measure>
    <time_frame>30 days</time_frame>
    <description>Presence of respiratory failure in the post-operative period as defined in the clinical notes or discharge summaries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative ARDS</measure>
    <time_frame>30 days</time_frame>
    <description>ARDS diagnosed radiologically</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative sepsis</measure>
    <time_frame>30 days</time_frame>
    <description>Presence of sepsis in the post-operative period as defined in the clinical notes or discharge summaries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ITU/HDU admission</measure>
    <time_frame>30 days</time_frame>
    <description>ITU/HDU admission post-operatively</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Other complications</measure>
    <time_frame>30 days</time_frame>
    <description>Other documented post-operative complications</description>
  </other_outcome>
  <other_outcome>
    <measure>Peri-operative NLR</measure>
    <time_frame>First 3 post-operative days</time_frame>
    <description>Neutrophil:Lymphocyte Ratio will be recorded daily in the peri-operative period</description>
  </other_outcome>
  <other_outcome>
    <measure>Post-operative platelet counts</measure>
    <time_frame>First 3 post-operative days</time_frame>
    <description>Absolute platelet counts recorded daily in the peri-operative period</description>
  </other_outcome>
  <other_outcome>
    <measure>Post-operative coagulopathy</measure>
    <time_frame>First 3 post-operative days</time_frame>
    <description>Defined as the presence of increased PT (prothrombin time) OR APTT (activated partial thromboplastin time) OR TT (thrombin time) OR fibrinogen above 1.5X the upper limit of normal. Coagulation will either be defined as normal or abnormal for each patient if one or more of these derangement are identified.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">94</enrollment>
  <condition>COVID-19</condition>
  <condition>Emergency General Surgery</condition>
  <arm_group>
    <arm_group_label>Suspected or Confirmed COVID-19</arm_group_label>
    <description>All adult patients (&gt;17 years) undergoing emergency (laparotomy) surgery at a single centre (Queens Hospital, Romford, UK) with clinically or radiologically suspected COVID-19, or with viral PCR confirmation; diagnosis made 7-days before and 30-days after date of surgery in accordance with the COVIDsurg study criteria (3).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Negative or non-suspected COVID-19</arm_group_label>
    <description>All adult patients (&gt;17 years) undergoing emergency (laparotomy) surgery at a single centre (Queens Hospital, Romford, UK) without clinically or radiologically suspected COVID-19, or without viral PCR (Polymerase Chain Reaction) confirmation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Emergency Laparotomy</intervention_name>
    <description>All adult patients undergoing emergency laparotomy</description>
    <arm_group_label>Negative or non-suspected COVID-19</arm_group_label>
    <arm_group_label>Suspected or Confirmed COVID-19</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All adult patients (&gt;17 years) undergoing emergency (laparotomy) surgery at a single centre&#xD;
        (Queens Hospital, Romford, UK) regardless of COVID-19 status will be included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing emergency laparotomy (change made due to heterogeneity of&#xD;
             emergency general surgery)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inherited or acquired immunodeficiency (which may directly skew NLR)&#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>Queen's Hospital</name>
      <address>
        <city>Romford</city>
        <zip>RM7 0AG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://globalsurg.org/covidsurgcohortstudy/</url>
    <description>CovidSurg Cohort Study. Globalsurg.</description>
  </link>
  <reference>
    <citation>Vulliamy P, McCluney S, Mukherjee S, Ashby L, Amalesh T. Postoperative Elevation of the Neutrophil: Lymphocyte Ratio Predicts Complications Following Esophageal Resection. World J Surg. 2016 Jun;40(6):1397-403. doi: 10.1007/s00268-016-3427-z.</citation>
    <PMID>26813540</PMID>
  </reference>
  <reference>
    <citation>Cook EJ, Walsh SR, Farooq N, Alberts JC, Justin TA, Keeling NJ. Post-operative neutrophil-lymphocyte ratio predicts complications following colorectal surgery. Int J Surg. 2007 Feb;5(1):27-30. doi: 10.1016/j.ijsu.2006.05.013. Epub 2006 Jun 27.</citation>
    <PMID>17386911</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Barking, Havering and Redbridge University Hospitals NHS Trust</investigator_affiliation>
    <investigator_full_name>Nader Habib Bedwani</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </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>Yes</sharing_ipd>
    <ipd_description>All collected IPD regardless of inclusion in final publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data will be available from completion of study for 10 years</ipd_time_frame>
    <ipd_access_criteria>On request</ipd_access_criteria>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>285260</doc_id>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>https://www.myresearchproject.org.uk/</doc_url>
      <doc_comment>Data collection template available on IRAS (Integrated Research Application System) registration</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>285260</doc_id>
      <doc_type>Statistical Analysis Plan</doc_type>
      <doc_url>https://www.myresearchproject.org.uk/</doc_url>
      <doc_comment>Statistical analysis plan as part of protocol available on IRAS (Integrated Research Application System) registration</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>285260</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>https://www.myresearchproject.org.uk/</doc_url>
      <doc_comment>Protocol available on IRAS (Integrated Research Application System) registration</doc_comment>
    </study_doc>
  </study_docs>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 4, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT04419571/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04419571
org study id: 133196
nct id: NCT04419571
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
NLR has previously been observed to correlate with complications in upper GI (1) and
      colorectal (2) surgery. The investigators sought to assess if a similar correlation can be
      identified in emergency general surgical patients and if the presence of suspected or
      confirmed COVID-19 may impact on this.

      Given the heterogeneity of emergency general surgery the investigators therefore plan to
      perform a retrospective review of patients having emergency laparotomies only at a single NHS
      site during COVID-19 pandemic. Assessment of outcomes and Neutrophil:lymphocyte ratio as a
      predictor of outcomes will be completed. Outcomes will be completed in line with the recent
      COVIDSurg study criteria (3). The primary outcome is 30-day mortality. Secondary outcomes are
      7-day mortality, re-operation, length of stay, post-operative respiratory failure,
      post-operative ARDS (Acute Respiratory Distress Syndrome), post-operative sepsis and ITU
      (Intensive Therapy Unit)/HDU (High Dependency Unit) admission.
observational model: Cohort
time perspective: Retrospective
measure: 30-day mortality
time frame: 30 days
description: Mortality
measure: 7-day mortality
time frame: 7 days
description: Mortality
measure: Number of participants returning to theatre
time frame: 30 days
description: Re-operation
measure: Length of stay
time frame: 30 days
description: Inpatient stay during index admission
measure: Post-operative respiratory failure
time frame: 30 days
description: Presence of respiratory failure in the post-operative period as defined in the clinical notes or discharge summaries
measure: Post-operative ARDS
time frame: 30 days
description: ARDS diagnosed radiologically
measure: Post-operative sepsis
time frame: 30 days
description: Presence of sepsis in the post-operative period as defined in the clinical notes or discharge summaries
measure: ITU/HDU admission
time frame: 30 days
description: ITU/HDU admission post-operatively
measure: Other complications
time frame: 30 days
description: Other documented post-operative complications
measure: Peri-operative NLR
time frame: First 3 post-operative days
description: Neutrophil:Lymphocyte Ratio will be recorded daily in the peri-operative period
measure: Post-operative platelet counts
time frame: First 3 post-operative days
description: Absolute platelet counts recorded daily in the peri-operative period
measure: Post-operative coagulopathy
time frame: First 3 post-operative days
description: Defined as the presence of increased PT (prothrombin time) OR APTT (activated partial thromboplastin time) OR TT (thrombin time) OR fibrinogen above 1.5X the upper limit of normal. Coagulation will either be defined as normal or abnormal for each patient if one or more of these derangement are identified.
arm group label: Suspected or Confirmed COVID-19
description: All adult patients (>17 years) undergoing emergency (laparotomy) surgery at a single centre (Queens Hospital, Romford, UK) with clinically or radiologically suspected COVID-19, or with viral PCR confirmation; diagnosis made 7-days before and 30-days after date of surgery in accordance with the COVIDsurg study criteria (3).
arm group label: Negative or non-suspected COVID-19
description: All adult patients (>17 years) undergoing emergency (laparotomy) surgery at a single centre (Queens Hospital, Romford, UK) without clinically or radiologically suspected COVID-19, or without viral PCR (Polymerase Chain Reaction) confirmation.
intervention type: Procedure
intervention name: Emergency Laparotomy
description: All adult patients undergoing emergency laparotomy
arm group label: Negative or non-suspected COVID-19
arm group label: Suspected or Confirmed COVID-19
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: United Kingdom
url: https://globalsurg.org/covidsurgcohortstudy/
description: CovidSurg Cohort Study. Globalsurg.
citation: Vulliamy P, McCluney S, Mukherjee S, Ashby L, Amalesh T. Postoperative Elevation of the Neutrophil: Lymphocyte Ratio Predicts Complications Following Esophageal Resection. World J Surg. 2016 Jun;40(6):1397-403. doi: 10.1007/s00268-016-3427-z.
PMID: 26813540
citation: Cook EJ, Walsh SR, Farooq N, Alberts JC, Justin TA, Keeling NJ. Post-operative neutrophil-lymphocyte ratio predicts complications following colorectal surgery. Int J Surg. 2007 Feb;5(1):27-30. doi: 10.1016/j.ijsu.2006.05.013. Epub 2006 Jun 27.
PMID: 17386911
responsible party type: Principal Investigator
investigator affiliation: Barking, Havering and Redbridge University Hospitals NHS Trust
investigator full name: Nader Habib Bedwani
investigator title: Doctor
mesh term: COVID-19
mesh term: Emergencies
sharing ipd: Yes
ipd description: All collected IPD regardless of inclusion in final publication
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data will be available from completion of study for 10 years
ipd access criteria: On request
study doc: 
study doc: 
study doc: 
provided document: 