Surgical Admission at the Weekend and 30-day Mortality in Ontario, Canada: a Matched Cohort Study

May 8, 2018 updated by: James O'Leary, The Hospital for Sick Children

The Association Between Weekend Admission and Perioperative Adverse Outcomes for Adults Undergoing Surgery: A Matched Cohort Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

340000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G1X8
        • Recruiting
        • The Hospital for Sick Children
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any hospital admission in Ontario, Canada, between 2005 and 2015 for noncardiac surgery.

Description

Inclusion Criteria:

  • any hospital admission associated with an eligible surgical procedure in the Ontario discharge abstract database
  • between 2005 and 2015

Exclusion Criteria:

  • cardiothoracic or cardiology therapeutic procedures
  • non-surgical therapeutic interventions (e.g. dialysis)
  • obstetric procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Weekend admission
Adults admitted to hospital at the weekend (Saturday or Sunday) and who underwent surgery
Other: Hospital admission and surgery
Hospital admission and noncardiac surgery
Weekday admission
Adults admitted to hospital on a weekday (Tuesday to Thursday) and who underwent surgery
Other: Hospital admission and surgery
Hospital admission and noncardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30 day all cause mortality
Time Frame: 30 days from surgery
death
30 days from surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2016

Primary Completion (Anticipated)

September 15, 2018

Study Completion (Anticipated)

September 15, 2018

Study Registration Dates

First Submitted

August 29, 2017

First Submitted That Met QC Criteria

August 30, 2017

First Posted (Actual)

August 31, 2017

Study Record Updates

Last Update Posted (Actual)

May 9, 2018

Last Update Submitted That Met QC Criteria

May 8, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 1000055744

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study data used are housed at the Institute for Clinical Evaluative Sciences

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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