Health ServicesNCT03144544
Physiological Complexity of Pediatric Surgery Between Types of Hospitals
An observational study of Health Services, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 days to 17 years
- Conditions the study is for
- Health Services
- What is being tested?
- Pediatric surgical procedures
- Type of treatment
- Surgery or procedure
- How many people
- 830,830 participants
- Where
- 1 siteCanada
- Study dates
- 2 May 2016to 15 Jun 2017
- 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: Pediatric surgical procedures
Who may be able to join
- surgical procedures for individuals aged greater than 27 days and less than 18 years
Who cannot join
- newborns (0 to 27 days of age)
- records lacking a patient identifier or age
- non-surgical healthcare interventions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Health Services
- Being tested
- Pediatric surgical procedures
- Keywords
- Similarity, Diversity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric surgical proceduresProcedure or surgery
Eligible surgical procedures were identified using Canadian Classification of Health Interventions (CCI) therapeutic intervention codes.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric specialist hospitals | Free-standing hospitals providing tertiary pediatric referral services and performing pediatric surgical procedures Receives: Procedure: Pediatric surgical procedures | |
| Non-pediatric specialist hospitals | Other hospitals performing pediatric surgical procedures Receives: Procedure: Pediatric surgical procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of non-physiologically complex surgery
The proportion of non-physiologically complex pediatric surgical procedures
Measured: April 1, 2007 to March 31, 2015
Secondary outcomes (2)
Similarity
Similarity of different types of pediatric surgical procedures performed between hospitals was assessed using Yue and Clayton's index
Measured: April 1, 2007 to March 31, 2015
Diversity
Effective number of common procedures
Measured: April 1, 2007 to March 31, 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start2 May 2016
- Primary completion27 Oct 2016
- Study completion15 Jun 2017
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 Health ServicesStudies 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
- 830,830 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James O'Leary, The Hospital for Sick Children
- Investigators
- James D O'Leary, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144544
- Sponsor's protocol ID
- 1000053805
- Status last verified
- May 2018
- First submitted
- 4 May 2017
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All relevant data are within the paper.
Publications
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.
PubMed 29150783
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03144544
- Acronym / sponsor ID
- 1000053805
- Conditions
- Health Services
- Keywords
- Similarity, Diversity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 830,830 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 2 May 2016 (actual)
- Primary completion
- 27 Oct 2016 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 9 May 2017 (actual)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric specialist hospitals | – | Procedure: Pediatric surgical proceduresFree-standing hospitals providing tertiary pediatric referral services and performing pediatric surgical procedures |
| Non-pediatric specialist hospitals | – | Procedure: Pediatric surgical proceduresOther hospitals performing pediatric surgical procedures |
Who may qualify
- Ages
- 28 days to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric surgical procedures
Key inclusion criteria (1 listed)
- surgical procedures for individuals aged greater than 27 days and less than 18 years
Key exclusion criteria (3 listed)
- newborns (0 to 27 days of age)
- records lacking a patient identifier or age
- non-surgical healthcare interventions
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 |
|---|---|---|
| Pediatric surgical proceduresEligible surgical procedures were identified using Canadian Classification of Health Interventions (CCI) therapeutic intervention codes. | Procedure or surgery | Non-pediatric specialist hospitals, Pediatric specialist hospitals |
Primary outcome
Incidence of non-physiologically complex surgery
Time frame: April 1, 2007 to March 31, 2015
The proportion of non-physiologically complex pediatric surgical procedures
2 secondary outcomes
Similarity
Time frame: April 1, 2007 to March 31, 2015
Diversity
Time frame: April 1, 2007 to March 31, 2015
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 14 May 2018.
- Derived from this study: PubMed 29150783O'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.
- Individual participant dataSharing planned: No. All relevant data are within the paper.
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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, MD principal investigator
The Hospital for Sick Children
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 Health Services, 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 1 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 14 May 2018. 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?
Incidence of non-physiologically complex surgery (time frame: April 1, 2007 to March 31, 2015). 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 NCT03144544, 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 14 May 2018.