<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/NCT04479150</url>
  </required_header>
  <id_info>
    <org_study_id>COVIDCIR</org_study_id>
    <nct_id>NCT04479150</nct_id>
  </id_info>
  <brief_title>Complications and Mortality Following Emergency Digestive Surgery During the COVID-19 Pandemic</brief_title>
  <acronym>COVIDCIR</acronym>
  <official_title>Postoperative Complications and Mortality of Patients Submited to Emergency Digestive Surgery During the COVID-19 Pandemic (COVIDCIR Study): a Multicenter Cohorts' Study Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitari de Bellvitge</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut d'Investigació Biomèdica de Bellvitge</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Universitari de Bellvitge</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>
      A multi-centre, observational cohort study will be carried out in consecutive patients&#xD;
      operated on for urgent digestive pathology. Two cohorts will be defined: the 'pandemic'&#xD;
      cohort, which will include all patients [COVID-19-positive or negative] operated on for&#xD;
      emergency digestive pathology during the months of March to June 2020; and the control&#xD;
      cohort, which will include all patients operated on for emergency digestive pathology during&#xD;
      the months of March to June 2019.&#xD;
&#xD;
      Information will be gathered on demographic characteristics, clinical and analytical&#xD;
      parameters, scores on the usual risk scales for quality management in a General Surgery&#xD;
      service (POSSUM, P-POSSUM and LUCENTUM scores), prognostic factors applicable to all&#xD;
      patients, specific factors for patients infected with SARS-CoV-2, complications and&#xD;
      postoperative mortality (at 30 and 90 postoperative days). In the pandemic cohort it will be&#xD;
      detailed whether or not the patient was infected with SARS-CoV-2.&#xD;
&#xD;
      The main objective will be to determine the incidence of postoperative complications and&#xD;
      mortality. This variable will be analysed in the &quot;full analysis set&quot; population. Secondary&#xD;
      objective will be to develop a specific postoperative risk propensity model for SARS-CoV-2&#xD;
      infected patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COVIDCIR is an observational, multicenter, cohorts' study of patients undergoing&#xD;
      emergency/urgent gastrointestinal surgery during the period of maximum impact of the COVID-19&#xD;
      pandemic in Spain (from March 1st to June 30th, 2020).&#xD;
&#xD;
      The study conforms to the stipulations of the Declaration of Helsinki. The protocol was&#xD;
      approved by the local Institutional Review Board (Ethics and Clinical Investigation&#xD;
      Committee) and a waiver for written informed consent was given. The level of protection of&#xD;
      confidentiality, in terms of protection of personal data as required by Spanish Law (LOPD&#xD;
      3/2018), was also ensured.&#xD;
&#xD;
      A total of 30 surgical teams from different Spanish hospitals have been proposed as&#xD;
      participants in this study, which has been coordinated by the Department of General and&#xD;
      Digestive Surgery of Bellvitge University Hospital (L'Hospitalet del Llobregat, Barcelona,&#xD;
      Spain). All hospitals participating are from Spain, with different surgical capabilities.&#xD;
&#xD;
      Patients operated on for emergency/urgent gastrointestinal surgery constitute the target&#xD;
      population.&#xD;
&#xD;
      Inclusion criteria: ≥18 years, both genders, and operated on for urgent/emergency&#xD;
      gastrointestinal pathology.&#xD;
&#xD;
      Exclusion criteria: patients who have undergone a scheduled surgical intervention or patients&#xD;
      operated on by a service other than General and Digestive Surgery.&#xD;
&#xD;
      Three cohorts will be defined:&#xD;
&#xD;
      Cohort 1: Covid-19-positive (infected by SARS-CoV-2) patients who required emergency/urgent&#xD;
      gastrointestinal surgery from March 1st to June 30th, 2020 Cohort 2: Covid-19-negative (not&#xD;
      infected by SARS-CoV-2)patients who required emergency/urgent gastrointestinal surgery from&#xD;
      March 1st to June 30th, 2020.&#xD;
&#xD;
      Cohort 3: Consecutive patients who required emergency/urgent gastrointestinal surgery from&#xD;
      March 1st to June 30th, 2019 (control cohort of a &quot;pre-pandemic&quot; period, all patients&#xD;
      Covid-19-negative).&#xD;
&#xD;
      Primary outcome is 30-day postoperative mortality. Secondary variables are 90-day mortality,&#xD;
      postoperative complications, severa complications (graded as Clavien-Dindo score &gt;= IIIA),&#xD;
      and length of stay.&#xD;
&#xD;
      Main variables related to postoperative mortality and complications will be: Age,&#xD;
      comorbidities, ASA score, type of surgical pathology, type of performed surgery, POSSUM&#xD;
      score, P-POSSUM score, LUCENTUM score and specific analitic parameters for Covid-19 patients.&#xD;
&#xD;
      Baseline characteristics will be summarized using standard descriptive statistics, and a&#xD;
      descriptive and exploratory comparative analysis between cohorts will be carried out.&#xD;
&#xD;
      The cumulative incidence of mortality (and its 95% confident interval) and the incidence of&#xD;
      morbidity (and its 95% confident interval) at 30 and 90 days will be estimated by SARS-CoV-2&#xD;
      infection status (cohort 1) and in the control groups (cohorts 2 and 3).&#xD;
&#xD;
      To minimize the selection bias effect of potential confounders, propensity scores will be&#xD;
      estimated using a multinomial model to estimate the probability that subjects were&#xD;
      SARS-CoV-2-positive, SARS-CoV-2-negative. Then, subjects will be matched using the propensity&#xD;
      score. After matching, to identify imbalance between groups, the standardized mean difference&#xD;
      will be estimated and plotted. In the matched sample, the cumulative incidence of mortality&#xD;
      (and its 95% confidence interval) and the incidence of morbidity (and its 95% confidence&#xD;
      interval) at 30 and 90 days will be compared using a generalized linear model with a binomial&#xD;
      distribution and a logarithm link function. Those variables that remain imbalance between&#xD;
      groups after matching would be added to the model with an adjusting purpose.&#xD;
&#xD;
      A generalized linear model with a binomial distribution and a logarithm link function will be&#xD;
      used to estimate relative risk as a measure to indentify prognostic factors associated with&#xD;
      30 and 90 days mortality and morbidity incidences. Five predictive scores of postoperative&#xD;
      complications and/or mortality will be calculated: POSSUM-mortality, POSSUM-complications,&#xD;
      P-POSSUM, LUCENTUM-logistic regression and LUCENTUM-CHAID. Their applicability on the&#xD;
      complications and/or mortality prediction in COVID-19 pandemic will be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 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>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>30 Days</target_duration>
  <primary_outcome>
    <measure>30-day mortality</measure>
    <time_frame>30 days post-surgery</time_frame>
    <description>Mortality for any cause at 30 days after urgent gastrointestinal surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>90-day mortality</measure>
    <time_frame>90 days post-surgery</time_frame>
    <description>Mortality for any cause within 90 days of surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>30 days post-surgery</time_frame>
    <description>Postoperative complications within 30 days of surgery: classic postoperative complications, typical complications after digestive surgery and/or complications specifically associated with the evolution of COVID-19</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe complications</measure>
    <time_frame>30 days post-surgery</time_frame>
    <description>Postoperative complications within 30 days of surgery graded as equal or superior to IIIA grade according to the Clavien-Dindo classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lenght of stay</measure>
    <time_frame>90 days post-surgery</time_frame>
    <description>Number of days of hospital stay from the day of admission to the date of hospital discharge or death</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">5307</enrollment>
  <condition>Covid19</condition>
  <condition>Surgery--Complications</condition>
  <arm_group>
    <arm_group_label>Pandemic Covid-positive cohort</arm_group_label>
    <description>All Covid-positive patients operated on for emergency digestive pathology from March, 1st 2020 to June, 30th 2020</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pandemic Covid-negative cohort</arm_group_label>
    <description>All Covid-negative patients operated on for emergency digestive pathology from March, 1st 2020 to June, 30th 2020</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control cohort</arm_group_label>
    <description>Pre-pandemic cohort: all patients operated on for emergency digestive pathology from March, 1st 2020 to June, 30th 2019.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients operated on for emergency/urgent gastrointestinal surgery constitute the target&#xD;
        population.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients ≥18 years, both genders, and operated on for urgent/emergency gastrointestinal&#xD;
        pathology.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have undergone a scheduled surgical intervention or patients operated on&#xD;
             by a service other than General and Digestive Surgery.&#xD;
&#xD;
          -  Patients &lt; 18 years old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Javier Osorio, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitary de Bellvitge</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitari de Bellvitge</name>
      <address>
        <city>L'Hospitalet De Llobregat</city>
        <state>Barcelona</state>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>February 20, 2021</last_update_submitted>
  <last_update_submitted_qc>February 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitari de Bellvitge</investigator_affiliation>
    <investigator_full_name>Javier Osorio</investigator_full_name>
    <investigator_title>Javier Osorio</investigator_title>
  </responsible_party>
  <keyword>Covid19</keyword>
  <keyword>Emergency surgery</keyword>
  <keyword>Postoperative complications</keyword>
  <keyword>Postoperative mortality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Postoperative Complications</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/NCT04479150
org study id: COVIDCIR
nct id: NCT04479150
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A multi-centre, observational cohort study will be carried out in consecutive patients
      operated on for urgent digestive pathology. Two cohorts will be defined: the 'pandemic'
      cohort, which will include all patients [COVID-19-positive or negative] operated on for
      emergency digestive pathology during the months of March to June 2020; and the control
      cohort, which will include all patients operated on for emergency digestive pathology during
      the months of March to June 2019.

      Information will be gathered on demographic characteristics, clinical and analytical
      parameters, scores on the usual risk scales for quality management in a General Surgery
      service (POSSUM, P-POSSUM and LUCENTUM scores), prognostic factors applicable to all
      patients, specific factors for patients infected with SARS-CoV-2, complications and
      postoperative mortality (at 30 and 90 postoperative days). In the pandemic cohort it will be
      detailed whether or not the patient was infected with SARS-CoV-2.

      The main objective will be to determine the incidence of postoperative complications and
      mortality. This variable will be analysed in the "full analysis set" population. Secondary
      objective will be to develop a specific postoperative risk propensity model for SARS-CoV-2
      infected patients.
COVIDCIR is an observational, multicenter, cohorts' study of patients undergoing
      emergency/urgent gastrointestinal surgery during the period of maximum impact of the COVID-19
      pandemic in Spain (from March 1st to June 30th, 2020).

      The study conforms to the stipulations of the Declaration of Helsinki. The protocol was
      approved by the local Institutional Review Board (Ethics and Clinical Investigation
      Committee) and a waiver for written informed consent was given. The level of protection of
      confidentiality, in terms of protection of personal data as required by Spanish Law (LOPD
      3/2018), was also ensured.

      A total of 30 surgical teams from different Spanish hospitals have been proposed as
      participants in this study, which has been coordinated by the Department of General and
      Digestive Surgery of Bellvitge University Hospital (L'Hospitalet del Llobregat, Barcelona,
      Spain). All hospitals participating are from Spain, with different surgical capabilities.

      Patients operated on for emergency/urgent gastrointestinal surgery constitute the target
      population.

      Inclusion criteria: ≥18 years, both genders, and operated on for urgent/emergency
      gastrointestinal pathology.

      Exclusion criteria: patients who have undergone a scheduled surgical intervention or patients
      operated on by a service other than General and Digestive Surgery.

      Three cohorts will be defined:

      Cohort 1: Covid-19-positive (infected by SARS-CoV-2) patients who required emergency/urgent
      gastrointestinal surgery from March 1st to June 30th, 2020 Cohort 2: Covid-19-negative (not
      infected by SARS-CoV-2)patients who required emergency/urgent gastrointestinal surgery from
      March 1st to June 30th, 2020.

      Cohort 3: Consecutive patients who required emergency/urgent gastrointestinal surgery from
      March 1st to June 30th, 2019 (control cohort of a "pre-pandemic" period, all patients
      Covid-19-negative).

      Primary outcome is 30-day postoperative mortality. Secondary variables are 90-day mortality,
      postoperative complications, severa complications (graded as Clavien-Dindo score >= IIIA),
      and length of stay.

      Main variables related to postoperative mortality and complications will be: Age,
      comorbidities, ASA score, type of surgical pathology, type of performed surgery, POSSUM
      score, P-POSSUM score, LUCENTUM score and specific analitic parameters for Covid-19 patients.

      Baseline characteristics will be summarized using standard descriptive statistics, and a
      descriptive and exploratory comparative analysis between cohorts will be carried out.

      The cumulative incidence of mortality (and its 95% confident interval) and the incidence of
      morbidity (and its 95% confident interval) at 30 and 90 days will be estimated by SARS-CoV-2
      infection status (cohort 1) and in the control groups (cohorts 2 and 3).

      To minimize the selection bias effect of potential confounders, propensity scores will be
      estimated using a multinomial model to estimate the probability that subjects were
      SARS-CoV-2-positive, SARS-CoV-2-negative. Then, subjects will be matched using the propensity
      score. After matching, to identify imbalance between groups, the standardized mean difference
      will be estimated and plotted. In the matched sample, the cumulative incidence of mortality
      (and its 95% confidence interval) and the incidence of morbidity (and its 95% confidence
      interval) at 30 and 90 days will be compared using a generalized linear model with a binomial
      distribution and a logarithm link function. Those variables that remain imbalance between
      groups after matching would be added to the model with an adjusting purpose.

      A generalized linear model with a binomial distribution and a logarithm link function will be
      used to estimate relative risk as a measure to indentify prognostic factors associated with
      30 and 90 days mortality and morbidity incidences. Five predictive scores of postoperative
      complications and/or mortality will be calculated: POSSUM-mortality, POSSUM-complications,
      P-POSSUM, LUCENTUM-logistic regression and LUCENTUM-CHAID. Their applicability on the
      complications and/or mortality prediction in COVID-19 pandemic will be assessed.
observational model: Cohort
time perspective: Cross-Sectional
measure: 30-day mortality
time frame: 30 days post-surgery
description: Mortality for any cause at 30 days after urgent gastrointestinal surgery.
measure: 90-day mortality
time frame: 90 days post-surgery
description: Mortality for any cause within 90 days of surgery
measure: Postoperative complications
time frame: 30 days post-surgery
description: Postoperative complications within 30 days of surgery: classic postoperative complications, typical complications after digestive surgery and/or complications specifically associated with the evolution of COVID-19
measure: Severe complications
time frame: 30 days post-surgery
description: Postoperative complications within 30 days of surgery graded as equal or superior to IIIA grade according to the Clavien-Dindo classification
measure: Lenght of stay
time frame: 90 days post-surgery
description: Number of days of hospital stay from the day of admission to the date of hospital discharge or death
arm group label: Pandemic Covid-positive cohort
description: All Covid-positive patients operated on for emergency digestive pathology from March, 1st 2020 to June, 30th 2020
arm group label: Pandemic Covid-negative cohort
description: All Covid-negative patients operated on for emergency digestive pathology from March, 1st 2020 to June, 30th 2020
arm group label: Control cohort
description: Pre-pandemic cohort: all patients operated on for emergency digestive pathology from March, 1st 2020 to June, 30th 2019.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Javier Osorio, MD, PhD
role: Principal Investigator
affiliation: Hospital Universitary de Bellvitge
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitari de Bellvitge
investigator full name: Javier Osorio
investigator title: Javier Osorio
mesh term: COVID-19
mesh term: Emergencies
mesh term: Postoperative Complications
sharing ipd: Undecided