Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000866505p
Ethics application status
Submitted, not yet approved
Date submitted
8/05/2024
Date registered
15/07/2024
Date last updated
15/07/2024
Date data sharing statement initially provided
15/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Chronic pain following appendicectomy in children
Scientific title
The prevalence of chronic post-surgical pain following paediatric appendicectomy
Secondary ID [1] 312101 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Appendicitis 333735 0
Chronic Pain 333736 0
Condition category
Condition code
Anaesthesiology 330420 330420 0 0
Pain management
Oral and Gastrointestinal 330907 330907 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The exposure will be to laparoscopic with or without open appendicectomy and observation period will be up to 12 weeks post-operatively. Data to be collected will include questionnaires about presence or absence of pain and whether participants have returned to normal functioning in a 5 minute phone call at 3 weeks and 15 minute call at 12 weeks. The 12 week telephone call will also include a series of questionnaires from the paediatric electronic persistent pain outcome collaboration (ePPOC) including the Brief Pain Inventory (BPI), Functional Disability Index (FDI), Paediatric Quality of Life Inventory (PedsQL), Bath Adolescent Pain Questionnaire (BAPQ5).
Intervention code [1] 328540 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338170 0
Prevalence of chronic postsurgical pain in patients 2-16 years of age after appendicectomy
Timepoint [1] 338170 0
Phone interviews to be conducted at 3 weeks and 12 weeks post-operatively.
Secondary outcome [1] 434795 0
Intensity and severity of chronic postsurgical pain
Timepoint [1] 434795 0
Phone interview at 12 weeks
Secondary outcome [2] 434796 0
Prevalence and nature of pain-related worries
Timepoint [2] 434796 0
Phone interview at 12 weeks.
Secondary outcome [3] 437511 0
Difficulty or disability with daily function
Timepoint [3] 437511 0
Phone interview at 12 weeks.
Secondary outcome [4] 437512 0
Health-related quality of life
Timepoint [4] 437512 0
Phone interview at 12 weeks.

Eligibility
Key inclusion criteria
1. Is between the ages of 2 and 16 at enrolment
2. Has undergone/is undergoing appendicectomy for presumed appendicitis
3. Has provided consent or has consent from a legally acceptable representative, who is capable of understanding the informed consent document, on the participant’s behalf
Minimum age
2 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Expected to be unable to be contacted for follow up
2. Unable to complete a questionnaire due to language barrier

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
The primary outcome for this study is the prevalence of chronic post-surgical pain following paediatric appendicectomy. A convenience sample of 100 (anticipating a dropout rate of around 10%) has been chosen. If we determined 5% prevalence then the 95% confidence interval would be 1.5-11% which provides an acceptable degree of precision. If we found a 0% prevalence the upper bound of the 95% confidence interval would be 3.6%. If we determined a 10% prevalence then the 95% confidence interval would be 5-17% and we will then conduct a series of exploratory univariate analyses to assess if the pain is associated with any particular patient or surgical factor.

Following determination of prevalence for chronic post-surgical pain, we will assess descriptive statistics of the population (age, gender, weight, BMI, surgical indication, surgical type) and then impact of chronic pain if present (pain questionnaires). All data will be expressed as a number, range, percent and mean and standard deviation as appropriate. The nature of the pain will be described in descriptively. For the exploratory analysis where pain is present or not numerical data between groups will be compared with a Student's t-test. Associations between categorical variables will be analysed using Pearson's chi squared tests. Logistical regressions will be performed to identify relationships between variables and chronic post-surgical pain. A value p < 0.05 will be considered statically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/07/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26519 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 42560 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 316459 0
Other
Name [1] 316459 0
Murdoch Childrens' Research Institute
Country [1] 316459 0
Australia
Funding source category [2] 316840 0
Hospital
Name [2] 316840 0
Royal Children's Hospital Melbourne
Country [2] 316840 0
Australia
Primary sponsor type
Other
Name
Murdoch Childrens' Research Institute
Address
Country
Australia
Secondary sponsor category [1] 318633 0
Hospital
Name [1] 318633 0
Royal Childrens' Hospital Melbourne
Address [1] 318633 0
Country [1] 318633 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315249 0
The Royal Children’s Hospital Human Research Ethics Committee
Ethics committee address [1] 315249 0
Ethics committee country [1] 315249 0
Australia
Date submitted for ethics approval [1] 315249 0
29/06/2024
Approval date [1] 315249 0
Ethics approval number [1] 315249 0

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

Contacts
Principal investigator
Name 134130 0
Dr Simran Rajpal
Address 134130 0
Murdoch Children's Research Institute, 50 Flemington Rd, Parkville VIC 3052
Country 134130 0
Australia
Phone 134130 0
+61 3 8341 6200
Fax 134130 0
Email 134130 0
[email protected]
Contact person for public queries
Name 134131 0
Simran Rajpal
Address 134131 0
Murdoch Children's Research Institute, 50 Flemington Rd, Parkville VIC 3052
Country 134131 0
Australia
Phone 134131 0
+61 3 8341 6200
Fax 134131 0
Email 134131 0
[email protected]
Contact person for scientific queries
Name 134132 0
Simran Rajpal
Address 134132 0
Murdoch Children's Research Institute, 50 Flemington Rd, Parkville VIC 3052
Country 134132 0
Australia
Phone 134132 0
+61 3 8341 6200
Fax 134132 0
Email 134132 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



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.