Evaluating the Effect of Surgical Safety Checklists on Perioperative Complications in Children

Postoperative Complications Clinical Trial

Official title:

Evaluating the Effect of Surgical Safety Checklists on Perioperative Complications in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02419053
• Other study ID #: 1000046196
• Status: Completed
• Phase: N/A
• First received: April 13, 2015
• Last updated: October 12, 2016
• Start date: October 2008
• Est. completion date: September 2011

Study information

• Verified date: October 2016
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to see if the surgical safety checklist is associated with a reduction in perioperative complications for children undergoing surgery in Ontario, Canada.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28772
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

• Surgical admission, with a noncardiac surgical interventions

• Aged between >28 days and <18years on the day of the surgical intervention

Exclusion Criteria:

• Non-surgical admission

• Surgical interventions with <10 per group

• Cardio-thoracic and interventional cardiology procedures

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Intraoperative Complications
• Postoperative Complications

Intervention

Other:
• Surgical Safety Checklist
An Ontario hospital-wide introduction of a surgical safety checklist based on the WHO guidelines, as mandated by the Ontario Ministry of Health

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Institute for Clinical Evaluative Sciences

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative complications	Composite outcome, complications included were death (all-causes), acute renal failure, cardiac arrest, complications of implants or grafts, decubitus ulcer, deep vein thrombosis, disruption of wound, electrolyte or acid-base abnormality, hemorrhage or hematoma, pulmonary embolism, pulmonary collapse or pneumonia, surgical site infection, sepsis, shock, stroke, and vascular graft failure	30-days after surgery	No
Secondary	Healthcare utilization - proportion of Emergency Room visits	Number of Emergency Room visits	30-days after surgery	No
Secondary	Healthcare utilization - rate of unplanned return to the operating room	Unplanned return to the operating room	30-days after surgery	No
Secondary	Healthcare utilization - length of hospital stay	Length of hospital stay	30-days after surgery	No