<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/NCT03268044</url>
  </required_header>
  <id_info>
    <org_study_id>1000055744</org_study_id>
    <nct_id>NCT03268044</nct_id>
  </id_info>
  <brief_title>Surgical Admission at the Weekend and 30-day Mortality in Ontario, Canada: a Matched Cohort Study</brief_title>
  <official_title>The Association Between Weekend Admission and Perioperative Adverse Outcomes for Adults Undergoing Surgery: A Matched Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hospital for Sick Children</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>
      Surgery is performed at the weekend for risk to life or limb, when mandated by clinical&#xD;
      guidelines, or depending on resource availability. Weekend healthcare interventions have been&#xD;
      associated with increased mortality and adverse clinical outcomes in the majority of the&#xD;
      literature examining the weekend effect, but these findings are not consistent. Results from&#xD;
      recent observational studies argue against a true weekend effect. Higher rates of adverse&#xD;
      outcomes associated with hospital activity at weekends do not appear to be due to altered&#xD;
      medical staffing as commonly hypothesized, but are thought to be in part a result of data&#xD;
      artefact and confounding by severity or indication. For this study, we hypothesized that&#xD;
      patients who are admitted to hospital at the weekend and require surgery have an increased&#xD;
      risk of death compared with patients who are admitted and undergo surgery on weekdays. The&#xD;
      primary aim was to examine whether patients who underwent surgery and were admitted at the&#xD;
      weekend had an increased risk of 30 day all-cause mortality compared with patients who were&#xD;
      admitted and underwent surgery on weekdays; secondary aim was to examine whether the timing&#xD;
      of surgery (i.e., surgery on the same weekend or surgery on a subsequent weekday) for&#xD;
      patients admitted at the weekend is associated with increased risk of 30 day all-cause&#xD;
      mortality.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 18, 2016</start_date>
  <completion_date type="Anticipated">September 15, 2018</completion_date>
  <primary_completion_date type="Anticipated">September 15, 2018</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 all cause mortality</measure>
    <time_frame>30 days from surgery</time_frame>
    <description>death</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">340000</enrollment>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Weekend admission</arm_group_label>
    <description>Adults admitted to hospital at the weekend (Saturday or Sunday) and who underwent surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Weekday admission</arm_group_label>
    <description>Adults admitted to hospital on a weekday (Tuesday to Thursday) and who underwent surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hospital admission and surgery</intervention_name>
    <description>Hospital admission and noncardiac surgery</description>
    <arm_group_label>Weekday admission</arm_group_label>
    <arm_group_label>Weekend admission</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Any hospital admission in Ontario, Canada, between 2005 and 2015 for noncardiac surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  any hospital admission associated with an eligible surgical procedure in the Ontario&#xD;
             discharge abstract database&#xD;
&#xD;
          -  between 2005 and 2015&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cardiothoracic or cardiology therapeutic procedures&#xD;
&#xD;
          -  non-surgical therapeutic interventions (e.g. dialysis)&#xD;
&#xD;
          -  obstetric procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>James D O'Leary, MBBCh</last_name>
      <phone>4168131500</phone>
      <phone_ext>228845</phone_ext>
      <email>james.oleary@sickkids.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>May 8, 2018</last_update_submitted>
  <last_update_submitted_qc>May 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hospital for Sick Children</investigator_affiliation>
    <investigator_full_name>James O'Leary</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Study data used are housed at the Institute for Clinical Evaluative Sciences</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/NCT03268044
org study id: 1000055744
nct id: NCT03268044
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Surgery is performed at the weekend for risk to life or limb, when mandated by clinical
      guidelines, or depending on resource availability. Weekend healthcare interventions have been
      associated with increased mortality and adverse clinical outcomes in the majority of the
      literature examining the weekend effect, but these findings are not consistent. Results from
      recent observational studies argue against a true weekend effect. Higher rates of adverse
      outcomes associated with hospital activity at weekends do not appear to be due to altered
      medical staffing as commonly hypothesized, but are thought to be in part a result of data
      artefact and confounding by severity or indication. For this study, we hypothesized that
      patients who are admitted to hospital at the weekend and require surgery have an increased
      risk of death compared with patients who are admitted and undergo surgery on weekdays. The
      primary aim was to examine whether patients who underwent surgery and were admitted at the
      weekend had an increased risk of 30 day all-cause mortality compared with patients who were
      admitted and underwent surgery on weekdays; secondary aim was to examine whether the timing
      of surgery (i.e., surgery on the same weekend or surgery on a subsequent weekday) for
      patients admitted at the weekend is associated with increased risk of 30 day all-cause
      mortality.
observational model: Cohort
time perspective: Retrospective
measure: 30 day all cause mortality
time frame: 30 days from surgery
description: death
arm group label: Weekend admission
description: Adults admitted to hospital at the weekend (Saturday or Sunday) and who underwent surgery
arm group label: Weekday admission
description: Adults admitted to hospital on a weekday (Tuesday to Thursday) and who underwent surgery
intervention type: Other
intervention name: Hospital admission and surgery
description: Hospital admission and noncardiac surgery
arm group label: Weekday admission
arm group label: Weekend admission
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: James O'Leary
investigator title: Principal Investigator
sharing ipd: No
ipd description: Study data used are housed at the Institute for Clinical Evaluative Sciences