Intraoperative ComplicationsNCT02419053
Evaluating the Effect of Surgical Safety Checklists on Perioperative Complications in Children
An observational study of Intraoperative Complications and Postoperative Complications, run by The Hospital for Sick Children at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 28 days to 17 years
- Conditions the study is for
- Intraoperative Complications, Postoperative Complications
- What is being tested?
- Surgical Safety Checklist
- How many people
- 28,772 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2008to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Surgical interventions performed in Ontario for children
Who may be able to join
- Surgical admission, with a noncardiac surgical interventions
- Aged between >28 days and <18years on the day of the surgical intervention
Who cannot join
- Non-surgical admission
- Surgical interventions with <10 per group
- Cardio-thoracic and interventional cardiology procedures
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Surgical Safety Checklist
- Keywords
- Surgical safety checklist, perioperative complications, pediatric
- Medical subject headings
- Intraoperative Complications, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Safety ChecklistOther
An Ontario hospital-wide introduction of a surgical safety checklist based on the WHO guidelines, as mandated by the Ontario Ministry of Health
| Study group | Role | What they receive |
|---|---|---|
| Pre-checklist | Surgical interventions performed for children before the introduction of the surgical safety checklist in Ontario, from October 2008 to September 2009. | |
| Post-checklist | Surgical interventions performed for children after the introduction of the surgical safety checklist in Ontario, from October 2010 to September 2011. Receives: Other: Surgical Safety Checklist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30-days after surgery
Secondary outcomes (3)
Healthcare utilization - proportion of Emergency Room visits
Number of Emergency Room visits
Measured: 30-days after surgery
Healthcare utilization - rate of unplanned return to the operating room
Unplanned return to the operating room
Measured: 30-days after surgery
Healthcare utilization - length of hospital stay
Length of hospital stay
Measured: 30-days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startOct 2008
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intraoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 28,772 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Clinical Evaluative Sciences
- Responsible party
- Principal investigator, James O'Leary, The Hospital for Sick Children
- Investigators
- James D O'Leary, MBBCh, Principal investigator, The Hospital for Sick Children, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419053
- Sponsor's protocol ID
- 1000046196
- Status last verified
- Oct 2016
- First submitted
- 13 Apr 2015
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Leary JD, Wijeysundera DN, Crawford MW. Effect of surgical safety checklists on pediatric surgical complications in Ontario. CMAJ. 2016 Jun 14;188(9):E191-E198. doi: 10.1503/cmaj.151333. Epub 2016 Mar 14.
PubMed 26976960
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Surgical Safety Checklists on Perioperative Complications in Children
- ClinicalTrials.gov ID
- NCT02419053
- Acronym / sponsor ID
- 1000046196
- Keywords
- Surgical safety checklist, perioperative complications, pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28,772 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Institute for Clinical Evaluative Sciences
- Study start
- Oct 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-checklist | – | –Surgical interventions performed for children before the introduction of the surgical safety checklist in Ontario, from October 2008 to September 2009. |
| Post-checklist | – | Other: Surgical Safety ChecklistSurgical interventions performed for children after the introduction of the surgical safety checklist in Ontario, from October 2010 to September 2011. |
Who may qualify
- Ages
- 28 days to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Surgical interventions performed in Ontario for children
Key inclusion criteria (2 listed)
- Surgical admission, with a noncardiac surgical interventions
- Aged between >28 days and <18years on the day of the surgical intervention
Key exclusion criteria (3 listed)
- Non-surgical admission
- Surgical interventions with <10 per group
- Cardio-thoracic and interventional cardiology procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical Safety ChecklistAn Ontario hospital-wide introduction of a surgical safety checklist based on the WHO guidelines, as mandated by the Ontario Ministry of Health | Other | Post-checklist |
Primary outcome
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
3 secondary outcomes
Healthcare utilization - proportion of Emergency Room visits
Time frame: 30-days after surgery
Healthcare utilization - rate of unplanned return to the operating room
Time frame: 30-days after surgery
Healthcare utilization - length of hospital stay
Time frame: 30-days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- Derived from this study: PubMed 26976960O'Leary JD, Wijeysundera DN, Crawford MW. Effect of surgical safety checklists on pediatric surgical complications in Ontario. CMAJ. 2016 Jun 14;188(9):E191-E198. doi: 10.1503/cmaj.151333. Epub 2016 Mar 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James D O'Leary, MBBCh principal investigator
The Hospital for Sick Children, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraoperative Complications and Postoperative Complications, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative complications (time frame: 30-days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02419053, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2016.