Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001293752
Ethics application status
Approved
Date submitted
30/09/2022
Date registered
6/10/2022
Date last updated
16/06/2024
Date data sharing statement initially provided
6/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Study of Paediatric Appendicitis Scores and Management Strategies in Children Aged 5 to < 18 years presenting to Australian and New Zealand Emergency Departments
Scientific title
A prospective multicentred observational non-interventional cohort study reviewing the accuracy (sensitivity, specificity, negative predictive value, positive predictive value, negative likelihood ratio, positive likelihood ratio, and area under curve of receiver operating characteristic curve) of clinical prediction scores for appendicitis in children aged 5 to < 18 years presenting to Australian and New Zealand Emergency Departments.
Secondary ID [1] 308086 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SPASMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
appendicitis
 327776 0
abdominal pain 327777 0
Condition category
Condition code
Emergency medicine 324846 324846 0 0
Other emergency care
Surgery 324847 324847 0 0
Other surgery
Public Health 324886 324886 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a study looking at clinical prediction scores for the diagnosis of paediatric appendicitis in children aged 5 to <18 years during their Emergency Department stay.

Data collected relating to their hospital presentation will include demographic data (sex, date of birth), eligibility (inclusion and exclusion criteria), clinician seniority and perceived likelihood of appendicitis on a Visual Analog Scale at a single time point at the point of care, history of presenting complaint (nature of abdominal pain, anorexia, nausea, vomiting, dysuria/frequency), and examination findings (area of tenderness, presence of rebound/cough/percussion tenderness, abdominal guarding, Rovsing’s sign, nature of bowel sounds, abdominal rigidity, temperature), bloods (white cell count, absolute neutrophil count, neutrophilia, C-reactive protein), urinalysis (presence of leukocytes and/or nitrites); prehospital management; management and imaging undertaken elsewhere; time-related data (times of triage, clinician evaluation, ED and hospital discharge); duration of ED and hospital stay; admission status; specialty unit consultations; analgesia; observation duration; intensive care admission, related surgical interventions; other significant pathology or adverse events, and mortality.

Besides the data about their hospital presentation that will be collected by clinicians with no active involvement from participants, follow up contact will be undertaken on all eligible patients except for the following cases: (1) parent/guardian declined follow up on initial presentation, (2) participant admitted under an inpatient medical or surgical team and no representation to ED within the follow up period of 30 days, or (3) participant identified by site research team to have experienced clinically significant adverse events. The follow-up contact planned to be conducted 30 days after presentation will be completed by the site research team. This will occur via a telephone call or email/text. A maximum of three contact attempts will be made with at least one telephone contact attempted after working hours. If more than 60 days have elapsed from the time of presentation, or if there have been three failed contact attempts, the patient follow-up will be regarded as unsuccessful. The medical record for patients unable to be reached will also be reviewed and if sufficient information is documented in the medical record, this information may be used to substitute for failed contact. The following data will be collected: relevant physician contacts; need for and duration of ED and/or hospital admissions including investigations (with review of the relevant medical record); duration of missing out on school/work; and related surgical interventions.

The duration of observation will be all patients presenting to participating hospital EDs during the study period. This is anticipated to be approximately a year from the commencement of the project (mid 2023-early 2024) based on the estimated annual number of appendicitis seen at the participating hospital EDs.
Intervention code [1] 324533 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332661 0
Presence of appendicitis confirmed through histopathology report when available, or operation report if not available
Timepoint [1] 332661 0
Within 7 days of hospital presentation
Secondary outcome [1] 414312 0
Complex appendicitis - this will be through data-linkage to medical records (imaging, histopathological, and operative findings) and telephone follow up for potential missed cases who present to non-study sites
Timepoint [1] 414312 0
Within 7 days of hospital presentation
Secondary outcome [2] 414313 0
Negative appendicectomy - this will be through data-linkage to medical record (histopathological, and operative findings) and telephone follow up for potential missed cases who present to non-study sites
Timepoint [2] 414313 0
Within 7 days of hospital presentation
Secondary outcome [3] 414314 0
Missed appendicitis case - this will be through data-linkage to medical record (imaging, histopathological, and operative findings) and telephone follow up for potential missed cases who present to non-study sites
Timepoint [3] 414314 0
Within 60 days of hospital presentation
Secondary outcome [4] 414315 0
Length of hospitalisation - this will be through data-linkage to medical record
Timepoint [4] 414315 0
Within 7 days of hospital presentation
Secondary outcome [5] 414316 0
Rates of investigations - this will be through data-linkage to medical record and telephone follow up for potential missed cases who present to non-study sites
Timepoint [5] 414316 0
Within 7 days of hospital presentation
Secondary outcome [6] 414317 0
Rates of interventions- this will be through data-linkage to medical record and telephone follow up for potential missed cases who present to non-study sites
Timepoint [6] 414317 0
Within 7 days of hospital presentation

Eligibility
Key inclusion criteria
1) Age 5 years to <18 years
2) Presentation with generalised or right-sided abdominal pain
3) Duration of pain for less than or equal to 7 days (less than or equal to 168 hours)
4) Clinician concern for the possible diagnosis of appendicitis as defined by:
i. Investigations performed (bloods/imaging, including external investigations)
ii. Surgical consultation to assess patient for appendicitis
iii. Senior clinician consultation to assess patient for appendicitis
iv. Period of observation in ED to re-assess patient for appendicitis
Minimum age
5 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Abdominal trauma which required medical review within last 7 days
2) Previous significant abdominal surgery (e.g. appendectomy, short gut, ileostomy, Hirschsprungs)
3) Chronic illnesses which may affect the abdomen (including inflammatory bowel disease, chronic pancreatitis, cystic fibrosis, sickle cell anaemia)
4) Pregnancy
5) Inability to obtain accurate history (e.g. parent/guardian unavailable, language other than English AND no interpreter available, or patient non-verbal due to pre-existing medical condition)

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
We will follow STAndards for the Reporting of Diagnostic accuracy studies (STARD) 2015 guidelines for statistics. The AUC will be calculated for the various published CPSs and the clinician gestalt for the outcome of appendicitis. The sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), negative likelihood ratio (LR-), positive likelihood ratio (LR+), and missed appendicitis rate will be calculated based on the published cut offs for each score. An estimated enrolment number of 2000 participants with 360 true appendicitis cases within a one-year period at the principal study site will provide sufficient power to find a 0.05 difference in AUC between the CPSs and have a 95% confidence interval around the ROC curve AUC ranging from ±1.5% for an AUC point estimate of 95% to ±2.8% for an AUC point estimate of 75%.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2023
Actual
1/08/2023
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
30/08/2025
Actual
Sample size
Target
2000
Accrual to date
1050
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,WA,VIC
Recruitment hospital [1] 23274 0
Perth Children's Hospital - Nedlands
Recruitment hospital [2] 23275 0
Monash Children’s Hospital - Clayton
Recruitment hospital [3] 25200 0
Royal Hobart Hospital - Hobart
Recruitment hospital [4] 25201 0
Sunshine Hospital - St Albans
Recruitment hospital [5] 25202 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [6] 25203 0
Gold Coast University Hospital - Southport
Recruitment hospital [7] 25204 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [8] 25205 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 38643 0
6009 - Nedlands
Recruitment postcode(s) [2] 38644 0
3168 - Clayton
Recruitment postcode(s) [3] 40870 0
7000 - Hobart
Recruitment postcode(s) [4] 40871 0
3021 - St Albans
Recruitment postcode(s) [5] 40872 0
2145 - Westmead
Recruitment postcode(s) [6] 40873 0
4215 - Southport
Recruitment postcode(s) [7] 40874 0
4101 - South Brisbane
Recruitment postcode(s) [8] 40875 0
3052 - Parkville
Recruitment outside Australia
Country [1] 25023 0
New Zealand
State/province [1] 25023 0
Auckland

Funding & Sponsors
Funding source category [1] 312340 0
Charities/Societies/Foundations
Name [1] 312340 0
Channel 7 Telethon Trust
Country [1] 312340 0
Australia
Primary sponsor type
Individual
Name
Professor Meredith Borland
Address
Perth Children's Hospital
15 Hospital Ave Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 313903 0
Individual
Name [1] 313903 0
Wei Hao Lee
Address [1] 313903 0
Perth Children's Hospital
15 Hospital Ave Nedlands WA 6009
Country [1] 313903 0
Australia
Secondary sponsor category [2] 318958 0
Charities/Societies/Foundations
Name [2] 318958 0
Emergency Medicine Foundation
Address [2] 318958 0
Country [2] 318958 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311706 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 311706 0
Ethics committee country [1] 311706 0
Australia
Date submitted for ethics approval [1] 311706 0
31/05/2023
Approval date [1] 311706 0
01/06/2023
Ethics approval number [1] 311706 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122070 0
Prof Meredith Borland
Address 122070 0
Perth Children's Hospital
15 Hospital Ave
Nedlands WA 6009
Country 122070 0
Australia
Phone 122070 0
+61 8 64564988
Fax 122070 0
Email 122070 0
[email protected]
Contact person for public queries
Name 122071 0
Meredith Borland
Address 122071 0
Perth Children's Hospital
15 Hospital Ave
Nedlands WA 6009
Country 122071 0
Australia
Phone 122071 0
+61 8 64564988
Fax 122071 0
Email 122071 0
[email protected]
Contact person for scientific queries
Name 122072 0
Meredith Borland
Address 122072 0
Perth Children's Hospital
15 Hospital Ave
Nedlands WA 6009
Country 122072 0
Australia
Phone 122072 0
+61 8 64564988
Fax 122072 0
Email 122072 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial after de-identification.
When will data be available (start and end dates)?
Beginning 3 months following main results publication; no end date determined.
Available to whom?
Case-by-case basis at the discretion of primary sponsor.
Available for what types of analyses?
For future studies and IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17227Ethical approval    384753-(Uploaded-04-10-2022-17-43-19)-Study-related document.PDF



Results publications and other study-related documents

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Current Study Results
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Update to Study Results
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