Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001191189
Ethics application status
Approved
Date submitted
31/07/2019
Date registered
26/08/2019
Date last updated
3/02/2020
Date data sharing statement initially provided
26/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Rurality and appendicitis in New Zealand children - a multicentre prospective study.
Scientific title
Comparison of anatomic severity of acute paediatric appendicitis in rural and urban pediatric patients: a multicentre, prospective cohort study
Secondary ID [1] 298796 0
Nil known.
Universal Trial Number (UTN)
U1111-1236-1865
Trial acronym
RURAL – Regional & Urban Risks of Appendicitis CompLications
Linked study record
This study is a follow up of ACTRN12619000894190. The information gathered from the preliminary qualitative study will guide data collection of this present study. This helps consider data points not obvious to the research team but may be very relevant to the studied population.

Health condition
Health condition(s) or problem(s) studied:
Appendicitis 313758 0
Condition category
Condition code
Surgery 312165 312165 0 0
Other surgery
Oral and Gastrointestinal 312166 312166 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Public Health 312167 312167 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
We aim to define the effect of rurality on the outcomes of paediatric appendicitis, a common and time dependent that can act a benchmark proxy for access to acute paediatric surgery. In order to enable robust comparison between rural and urban children we will create a rich data set encompassing prehospital patient variables, clinical and anatomical severity as well as post-operative complications.

In order to do this we will undertake a multicentre, prospective, observational cohort study led by surgical trainees and junior doctors across every hospital that performs acute appendicectomy on children in New Zealand.

We will collect data from consenting participants who 16 or under who undergo an acute appendicectomy or interventional radiologic procedure for acute appendicitis during our study period. This will involve prospectively recording relevant clinical, operative and histopathologic information whilst the child is in hospital. This will help us understand the severity of appendiciticits in these patients. In addition, the study collaborator (who will be a doctor or senior medical student) will also ask the parents/caregivers a brief set of questions regarding their prehospital illness and access to hospital. This will enable standardisation and documentation of relevant socioeconomic predictors of health.

Data will be collected on postoperative complications and collaborators will follow up with cases until 30 days postoperatively.
Intervention code [1] 315076 0
Diagnosis / Prognosis
Comparator / control treatment
Children from urban areas who undergo acute appendicectomy for appendicitis. This is defined as children whose main domicile resides within an city contains a hospital which routinely performs an acute appendicectomy on a paediatric patient.
Control group
Active

Outcomes
Primary outcome [1] 320888 0
American Association for the Surgery on Trauma (AAST) Grading System for Anatomic Severity. This system provides a more complete picture than the binary outcome of perforation.

The overall AAST grade is defined as the highest grade among the following components: clinical, radiographic, operative, and pathologic. It requires prospective assessment of clinical factors, intraoperative findings and is confirmed by post operative histo-pathologic assessment.
Timepoint [1] 320888 0
As measured during presentation for acute appendicitis.
Secondary outcome [1] 373255 0
Clinical severity of appendicitis as defined by the Paediatric Appendicitis Score (PAS)
Timepoint [1] 373255 0
As measured pre-operatively - this is defined as the time between presentation to a hospital with surgical capabilities and when the participant undergoes operative management of the same episode of appendicitis.
Secondary outcome [2] 373256 0
Post operative complications of appendicectomy as defined individually and by the Clavien Dindo Postoperative Complication Grade
Timepoint [2] 373256 0
0-30 postoperatively. Daily until discharge from hospital then a single follow up on post-op day 30.
Secondary outcome [3] 373257 0
Travel distance to from domicile to hospital where surgical management was obtained. This will be obtained through geocoding the address found in the patient's medical records in relation to the treating hospital. ArcGIS software will be used for this.
Timepoint [3] 373257 0
As recorded during index presentation for acute appendicitis.
Secondary outcome [4] 373701 0
Duration of pre-hospital symptomology (hours) as reported by the caregiver during admission. A study specific questionnaire will be utilised to gather this information.
Timepoint [4] 373701 0
As recorded during index presentation for acute appendicitis.
Secondary outcome [5] 373702 0
Method of travel to presenting hospital eg: private, public transport, ambulance, hospital, other as reported by the caregiver during admission. A study specific questionnaire will be utilised to gather this information.
Timepoint [5] 373702 0
As recorded during index presentation for acute appendicitis.

Eligibility
Key inclusion criteria
Participants will be recruited to the study only if they meet all the inclusion criteria and none of the exclusion criteria.

• Aged 16 or below and admitted to an acute surgical ward for investigation and/or management of suspected appendicitis.
• Underwent or is planned to undergo acute operative or procedural management for suspected/proven acute appendicitis. ( INCLUDES ‘negative appendicectomies’) OR child has definitive diagnosis of acute appendicitis on imaging and is being managed conservatively.
• Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant’s behalf
Minimum age
No limit
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Was transferred to another District Health Board pre-operatively
– however the receiving centre is able to enrol this patient.
• Admitted for an elective appendicectomy for a previous episode of appendicitis.
• Discharged without diagnosis of appendicitis and didn’t undergo acute appendicectomy.
• Inability or unwillingness of participant or legally acceptable representative to give written informed consent.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
We intend to prospectively recruit 291 inpatient paediatric cases of acute appendicitis. This preliminary power calculation is based off our proof-of-concept study and assuming a=0.05, ß=0.1 and an enrolment ratio of 1:1.5 of rural to urban children.. This number will be finalised after collaboration with professional statistical consultancy services.

Descriptive statistics will be used to describe basic demographics and distributions assessed for normality. Paired t -tests will be used to ascertain differences between continuous data assumed to be normally distributed, Wilcoxon–Mann– Whitney test used as a non-parametric analogue, chi-squared test for dichotomous variables and rank point-biserial correlation for ordinal variables.

No surgeon- or hospital-specific comparisons will be performed. Geographical analysis, travel distance calculation and geographic figures will be obtained using ArcGIS GIS Software Version 10.7.1. (ESRI Inc. Redlands, CA, USA).

Initial univariate analysis will be used to determine statistically significant variables, which after testing for multicollinearity will be used to create an ordinal regression model via backward elimination. Statistical analyses will be carried out using SPSS version 25.0 (SPSS Inc., Chicago, IL, USA). All tests will be two-sided and P -values of <0.05 considered statistically significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/01/2020
Actual
13/01/2020
Date of last participant enrolment
Anticipated
13/04/2020
Actual
Date of last data collection
Anticipated
13/05/2020
Actual
Sample size
Target
291
Accrual to date
13
Final
Recruitment outside Australia
Country [1] 21719 0
New Zealand
State/province [1] 21719 0
Northland
Country [2] 21720 0
New Zealand
State/province [2] 21720 0
Auckland
Country [3] 21721 0
New Zealand
State/province [3] 21721 0
South Island
Country [4] 22290 0
New Zealand
State/province [4] 22290 0
Waikato
Country [5] 22291 0
New Zealand
State/province [5] 22291 0
Wellington & Hutt Valley
Country [6] 22292 0
New Zealand
State/province [6] 22292 0
Bay of Plenty & Whakatane
Country [7] 22293 0
New Zealand
State/province [7] 22293 0
Whanganui
Country [8] 22294 0
New Zealand
State/province [8] 22294 0
Taranaki

Funding & Sponsors
Funding source category [1] 303354 0
Charities/Societies/Foundations
Name [1] 303354 0
Auckland Medical Research Foundation
Country [1] 303354 0
New Zealand
Primary sponsor type
Individual
Name
Dr Brodie Elliott
Address
General Surgical Office,
Ground Floor, Whangarei Hospital
Maunu Road
Private Bag 9742, Whangarei, 0148
New Zealand
Country
New Zealand
Secondary sponsor category [1] 303384 0
Other Collaborative groups
Name [1] 303384 0
Clinical Trials Network of Australia and New Zealand (CTANZ)
Address [1] 303384 0
Royal Australasian College of Surgeons
College of Surgeons' Gardens
250-290 Spring Street
East Melbourne VIC 3002 Australia
Country [1] 303384 0
Australia
Secondary sponsor category [2] 303455 0
Government body
Name [2] 303455 0
Northland District Health Board
Address [2] 303455 0
Whangarei Hospital, Northland District Health Board
Maunu Rd, Private Bag 9742, Whangarei 0148
New Zealand
Country [2] 303455 0
New Zealand
Secondary sponsor category [3] 303456 0
University
Name [3] 303456 0
University of Auckland
Address [3] 303456 0
Private Bag 92019
Victoria Street West
Auckland 1142
Country [3] 303456 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303883 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 303883 0
Ethics committee country [1] 303883 0
New Zealand
Date submitted for ethics approval [1] 303883 0
26/08/2019
Approval date [1] 303883 0
20/12/2019
Ethics approval number [1] 303883 0

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

Contacts
Principal investigator
Name 95118 0
Dr Brodie Elliott
Address 95118 0
Department of General Surgery
Whangarei Hospital, Maunu Road.
Private Bag 9742, Whangarei, 0148
Country 95118 0
New Zealand
Phone 95118 0
+64278285931
Fax 95118 0
Email 95118 0
[email protected]
Contact person for public queries
Name 95119 0
Brodie Elliott
Address 95119 0
Department of General Surgery
Whangarei Hospital, Maunu Road.
Private Bag 9742, Whangarei, 0148
Country 95119 0
New Zealand
Phone 95119 0
+64278285931
Fax 95119 0
Email 95119 0
[email protected]
Contact person for scientific queries
Name 95120 0
Brodie Elliott
Address 95120 0
Department of General Surgery
Whangarei Hospital, Maunu Road.
Private Bag 9742, Whangarei, 0148
Country 95120 0
New Zealand
Phone 95120 0
+64278285931
Fax 95120 0
Email 95120 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?
Anonymised and de-identified individual patient data.
When will data be available (start and end dates)?
Immediately following publication, with no end date determined at this point.
Available to whom?
Only researchers who provide a methodologically sound proposal and as a case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
For further health quality improvement programs, approved proposals and IPD meta-analyses.
How or where can data be obtained?
Access subject to approvals by Principal Investigator Dr Brodie Elliott, contactable at [email protected]


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.