Appendicectomy versus antibiotics for acute uncomplicated appendicitis in children: an open-label, international, multicentre, randomised, non-inferiority trial
Topic overview
International non-inferiority trial comparing antibiotics versus appendicectomy in 936 children aged 5-16 with uncomplicated appendicitis. Primary outcome was treatment failure within one year, defined as appendix removal in the antibiotic group or normal appendix on pathology in the surgery group.
Key takeaways
- Antibiotic treatment for uncomplicated appendicitis in children had 34% failure rate vs 7% for appendicectomy at 1-year follow-up.
- Non-operative management was statistically inferior to surgery using a 20% non-inferiority margin (difference 26.7%).
- Antibiotics group had 4.3x higher risk of mild-to-moderate adverse events compared to appendicectomy group.
- Most appendicectomy failures were negative appendicectomies (normal pathology), occurring in 7% of surgical patients.
- No deaths or serious adverse events occurred in either treatment group across 936 pediatric patients enrolled.
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