In Brief | Paediatrics & Neonatology | Surgery

Comparing Antibiotics and Appendicectomy for Uncomplicated Appendicitis in Children: Results from a Multicenter Non-Inferiority Trial

This article is a review of recent studies originally published in the Lancet,18 January 2025. It does not represent the original research, nor is it intended to replace the original research. Access the full Disclaimer Information.

Uncomplicated appendicitis in children is traditionally treated with appendicectomy; however, there has been growing support in the literature for non-operative management with antibiotics.¹

A 2020 study published in JAMA found that children with uncomplicated appendicitis treated with an initial non-operative strategy of antibiotics alone,  achieved a success rate of 67.1%. While the study did not meet its prespecified threshold for an acceptable success rate and the hypothesized difference in disability days was not statistically significant, support for antibiotics as a non-operative management strategy persists.² 

This study, published in the Lancet, aimed to assess whether antibiotic treatment for non-perforated appendicitis in children is inferior to appendicectomy, particularly in terms of treatment failure rates.


Study Purpose

The study aimed to assess whether antibiotics could serve as a viable alternative to surgery by comparing treatment failures over a 12-month period. 

The study was registered as ClinicalTrials.gov NCT02687464


Study Methodology

The study was a pragmatic, multicenter, parallel-group, unmasked, randomized, non-inferiority trial conducted across 11 children’s hospitals in Canada, the USA, Finland, Sweden, and Singapore. 

Children aged 5–16 years who were diagnosed with suspected non-perforated appendicitis based on clinical or radiological diagnosis were eligible for inclusion.

The patients were randomly assigned in a 1:1 ratio to receive either antibiotics or appendicectomy. 

The primary outcome measure was treatment failure within one year of random assignment. 

Treatment failure was defined differently for each group: in the antibiotic group, it was defined as the need for appendicectomy, while in the appendicectomy group, failure was defined as the removal of a normal appendix. 

A margin of 20% was used to assess non-inferiority, and interim analyses were performed to monitor the trial's progress.

Findings
 

936 patients were enrolled in the study: 459 were assigned to appendicectomy and 477 to the antibiotic cohort.

Of the 846 patients for whom primary outcome data was available at the 12-month follow-up, treatment failure had occurred in 34% (153/452) of the antibiotic group, compared to 7% (28/394) in the appendicectomy group. 

Of the patients in the antibiotic group who underwent appendicectomy, 13 (8%) had a normal appendix. 

There were no deaths or serious adverse events in either group, although researchers noted that the relative risk of mild-to-moderate adverse events in the antibiotic group compared to appendicectomy was 4.3 (95% CI: 2.1–8.7; p<0.0001).

Conclusion

The findings of this study indicate that, based on failure rates and the predefined non-inferiority margin of 20%, antibiotic management for non-perforated appendicitis was found to be inferior to appendicectomy. 

The higher failure rate and the increased likelihood of mild-to-moderate adverse events in the antibiotic group suggest that appendicectomy remains the preferred treatment for patients.
 

Access the original study

St Peter, S. D., et al. (2023). Appendicectomy versus antibiotics for acute uncomplicated appendicitis in children: An open-label, international, multicentre, randomised, non-inferiority trial. The Lancet, 405(10474), 233-240. https://doi.org/10.1016/S0140-6736(23)01757-6 

Additional References


1. Bhangu, A., Søreide, K., Di Saverio, S., Hansson Assarsson, J., & Drake, F. T. (2015). Acute appendicitis: Modern understanding of pathogenesis, diagnosis, and management. The Lancet, 386(10000), 1278–1287. https://doi.org/10.1016/S0140-6736(15)00275-5
 

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