Introduction This article presents an overview of a prospective randomised controlled non-inferiority study designed to evaluate the safety and effectiveness of non-operative management (NOM) with operative management in children with acute uncomplicated appendicitis (AUA). Here, we present the study protocol for this APRES study, a multicentre Australian study. The rationale and details of future analysis, in particular, non-inferiority calculations, cost-effectiveness, feasibility and acceptability of each intervention.
Design A multicentre, prospective randomised controlled clinical trial, conducted in 2 Australian tertiary paediatric hospitals.
Participants Children who meet the inclusion criteria of an age between 5 and 15 years and a clinical diagnosis of AUA will be invited to participate, and after consent will be randomised via a computer-based program into treatment groups. The study started in June 2016, and the target recruitment is 220 patients.
Interventions Children in the control group will be treated with prophylactic antibiotics and appendicectomy, and those in the intervention group will be treated with antibiotic therapy alone. Primary outcome measures include unplanned or unnecessary operation and complications at 30 days. Secondary outcomes include longer term complications within 1 year, length of stay, time off work and school analgesic requirements and cost.
Analysis Data analyses will be on the intention-to-treat principle using non-inferiority analysis. Analysis will include the Pearson χ2 test for categorical variables and independent sample t-test or Mann-Whitney test for continuous variables. Non-inferiority for NOM will be tested using 1-sided Wald tests with an α level of 0.05.
Ethics and dissemination The research has been approved by the Human Research Ethics Committee of the Sydney Children's Hospital Network. In addition, results will be reported through academic journals, seminars and conference presentations.
- PAEDIATRIC SURGERY
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Statistics from Altmetric.com
Contributors SA and JK initiated the project, and are the chief investigators. After a series of meetings and literature review, YCL drafted the protocol which was refined by SA and JK with input from the SCHN HREC scientific committee. Statistical advice was provided by Liz Barnes. JX drafted this manuscript based on the HREC approved protocol using the SPIRIT checklist.35 This was edited and refined by SA and JK.
Funding As an unfunded study, there are no competing financial interests for the investigators.
Competing interests None declared.
Ethics approval This protocol and associated documentation has been approved by the SCHN Human Research Ethics Committee (HREC/15/SCHN/266) with respect to scientific content and compliance with applicable research and human subject regulations.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The trial is registered on ClinicalTrials.gov and ANZCTR, both of which have open access. The participant information includes a flow sheet that summarises the study plan. The study findings will be presented in a report which will be submitted for publication in a relevant peer-reviewed journal to ensure dissemination to relevant healthcare professionals. Findings may also be submitted for presentation at local meetings or conferences. The final report will be made available to trial participants via the investigators. The participant-level data set may be made available for meta-analyses pending relevant HREC approval.
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.