NCT03144544

Brief Summary

When considered from a provincial perspective, quantification of surgical procedures undertaken by different hospitals and healthcare networks is necessary for informing resource allocation and modelling of healthcare services. The investigators hypothesized that i) non-physiologically complex surgical procedures would account for most (\>1/2) of pediatric surgical procedures performed at both pediatric specialist hospitals and the other hospitals performing pediatric surgery, ii) surgical discharges for non-physiologically complex surgical procedures would account for most (\>1/2) in-hospital bed nights among pediatric surgical admissions at both pediatric specialist hospitals and the other hospitals performing pediatric surgery, and iii) the relative distributions of non-physiologically complex surgical procedures, but not physiologically complex procedures, would be at least moderately similar between pediatric specialist hospitals and the other hospitals performing pediatric surgery. To test these 3 hypotheses, the specific objectives of this study were to estimate i) the proportion (primary outcome) of non-physiologically complex pediatric surgical procedures, and ii) the similarity and diversity (secondary outcomes) of non-physiologically and physiologically complex surgical procedures between the pediatric specialist hospitals and the other hospitals performing pediatric surgery in Ontario, Canada.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
830,830

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 9, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2017

Completed
Last Updated

May 14, 2018

Status Verified

May 1, 2018

Enrollment Period

6 months

First QC Date

May 4, 2017

Last Update Submit

May 8, 2018

Conditions

Keywords

SimilarityDiversity

Outcome Measures

Primary Outcomes (1)

  • Incidence of non-physiologically complex surgery

    The proportion of non-physiologically complex pediatric surgical procedures

    April 1, 2007 to March 31, 2015

Secondary Outcomes (2)

  • Similarity

    April 1, 2007 to March 31, 2015

  • Diversity

    April 1, 2007 to March 31, 2015

Study Arms (2)

Pediatric specialist hospitals

Free-standing hospitals providing tertiary pediatric referral services and performing pediatric surgical procedures

Procedure: Pediatric surgical procedures

Non-pediatric specialist hospitals

Other hospitals performing pediatric surgical procedures

Procedure: Pediatric surgical procedures

Interventions

Eligible surgical procedures were identified using Canadian Classification of Health Interventions (CCI) therapeutic intervention codes.

Non-pediatric specialist hospitalsPediatric specialist hospitals

Eligibility Criteria

Age28 Days - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric surgical procedures

You may qualify if:

  • surgical procedures for individuals aged greater than 27 days and less than 18 years

You may not qualify if:

  • newborns (0 to 27 days of age)
  • records lacking a patient identifier or age
  • non-surgical healthcare interventions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

Related Publications (1)

  • O'Leary JD, Dexter F, Faraoni D, Crawford MW. Incidence of non-physiologically complex surgical procedures performed in children: an Ontario population-based study of health administrative data. Can J Anaesth. 2018 Jan;65(1):23-33. doi: 10.1007/s12630-017-0993-y. Epub 2017 Nov 17.

Study Officials

  • James D O'Leary, MD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Anesthesiologist

Study Record Dates

First Submitted

May 4, 2017

First Posted

May 9, 2017

Study Start

May 2, 2016

Primary Completion

October 27, 2016

Study Completion

June 15, 2017

Last Updated

May 14, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

All relevant data are within the paper.

Locations