Recruiting

Observational Study

Sponsor:

The Hospital for Sick Children

Code:

NCT03268044

Conditions

Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hospital admission and surgery

Study Details

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.

Conditions

Surgery

Study ID

NCT03268044

Start date

Oct 18, 2016

Status verified date

May, 2018

Completion date

Sep 15, 2018

Anticipated

Primary completion date

Sep 15, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

340000 participants

Anticipated

Interventions and Outcome Measures

Arms

Weekend admission

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

Weekday admission

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

Interventions

Hospital admission and surgery

Hospital admission and noncardiac surgery

Primary outcome measure

  • 30 day all cause mortality [ Time Frame: 30 days from surgery ]

Central Contacts and Locations

Locations

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G1X8

Contacts

More Information

Sponsor

The Hospital for Sick Children

Last update posted

May 9, 2018

Last verified

May, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2018-05-09.