NCT03268044

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
340,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2018

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

1.9 years

First QC Date

August 29, 2017

Last Update Submit

May 8, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 30 day all cause mortality

    death

    30 days from surgery

Study Arms (2)

Weekend admission

Adults admitted to hospital at the weekend (Saturday or Sunday) and who underwent surgery

Other: Hospital admission and surgery

Weekday admission

Adults admitted to hospital on a weekday (Tuesday to Thursday) and who underwent surgery

Other: Hospital admission and surgery

Interventions

Hospital admission and noncardiac surgery

Weekday admissionWeekend admission

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 29, 2017

First Posted

August 31, 2017

Study Start

October 18, 2016

Primary Completion

September 15, 2018

Study Completion

September 15, 2018

Last Updated

May 9, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

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

Locations