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OpenTrials
Completed

NCT Number: NCT02419053

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

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.

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Key information

Conditions

Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

28 day–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical Safety Checklist

Other

An Ontario hospital-wide introduction of a surgical safety checklist based on the WHO guidelines, as mandated by the Ontario Ministry of Health

Primary outcomes

  1. Perioperative complications

    Time frame: 30-days after surgery

    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

Secondary outcomes

  1. Healthcare utilization - proportion of Emergency Room visits

    Time frame: 30-days after surgery

    Number of Emergency Room visits

  2. Healthcare utilization - rate of unplanned return to the operating room

    Time frame: 30-days after surgery

    Unplanned return to the operating room

  3. Healthcare utilization - length of hospital stay

    Time frame: 30-days after surgery

    Length of hospital stay

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Institute for Clinical Evaluative Sciences

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Apr 17, 2015
Registry last updated
Oct 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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