- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03144544
Physiological Complexity of Pediatric Surgery Between Types of Hospitals
May 8, 2018 updated by: James O'Leary, The Hospital for Sick Children
Incidences of Non-physiologically Complex Surgical Procedures Performed in Children and Their Similarity of Distribution Between Pediatric Specialist Hospitals and Other Hospitals Performing Pediatric Surgery
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
830830
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G1X8
- The Hospital for Sick Children
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 weeks to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Pediatric surgical procedures
Description
Inclusion Criteria:
- surgical procedures for individuals aged greater than 27 days and less than 18 years
Exclusion Criteria:
- newborns (0 to 27 days of age)
- records lacking a patient identifier or age
- non-surgical healthcare interventions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pediatric specialist hospitals
Free-standing hospitals providing tertiary pediatric referral services and performing pediatric surgical procedures
|
Eligible surgical procedures were identified using Canadian Classification of Health Interventions (CCI) therapeutic intervention codes.
|
Non-pediatric specialist hospitals
Other hospitals performing pediatric surgical procedures
|
Eligible surgical procedures were identified using Canadian Classification of Health Interventions (CCI) therapeutic intervention codes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of non-physiologically complex surgery
Time Frame: April 1, 2007 to March 31, 2015
|
The proportion of non-physiologically complex pediatric surgical procedures
|
April 1, 2007 to March 31, 2015
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Similarity
Time Frame: April 1, 2007 to March 31, 2015
|
Similarity of different types of pediatric surgical procedures performed between hospitals was assessed using Yue and Clayton's index
|
April 1, 2007 to March 31, 2015
|
Diversity
Time Frame: April 1, 2007 to March 31, 2015
|
Effective number of common procedures
|
April 1, 2007 to March 31, 2015
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: James D O'Leary, MD, The Hospital for Sick Children
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 2, 2016
Primary Completion (Actual)
October 27, 2016
Study Completion (Actual)
June 15, 2017
Study Registration Dates
First Submitted
May 4, 2017
First Submitted That Met QC Criteria
May 8, 2017
First Posted (Actual)
May 9, 2017
Study Record Updates
Last Update Posted (Actual)
May 14, 2018
Last Update Submitted That Met QC Criteria
May 8, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1000053805
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
All relevant data are within the paper.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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