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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03268044
Other study ID # 1000055744
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 18, 2016
Est. completion date September 15, 2018

Study information

Verified date May 2018
Source The Hospital for Sick Children
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 340000
Est. completion date September 15, 2018
Est. primary completion date September 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Hospital admission and surgery
Hospital admission and noncardiac surgery

Locations

Country Name City State
Canada The Hospital for Sick Children Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 30 day all cause mortality death 30 days from surgery
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