Non-operative management of uncomplicated appendicitis in children: a randomized, controlled, non-inferiority study evaluating safety and efficacy.

ABSTRACT

BACKGROUND: Appendicitis is the commonest paediatric surgical emergency. Adult studies suggest non-operative management (NOM) may have a place in care. There have been no adequately powered randomized controlled trials in children. OBJECTIVE: to determine the safety and efficacy of NOM for paediatric simple appendicitis. METHODS: A non-inferiority randomized controlled trial was conducted comparing operative (OM) to NOM of SA in children aged five-15 years. Primary outcome was treatment success (no unplanned or unnecessary operation, or complication) at 30 days and 12 months, with a non-inferiority margin of 15%. (anzctr.org.au ACTRN12616000788471). RESULTS: From 11 June 2016 to 30 November 2020, 222 children were randomized 94 (42.34%) to OM and 128 (57.66%) to NOM. Non-inferiority of NOM was not demonstrated at either time point, with 45.67% of NOM patients subsequently undergoing operation. There was no significant difference in complications. CONCLUSIONS: While noninferiority was not shown, NOM was safe, with no difference in adverse outcomes between the two groups. Further research to refine the place of NOM of simple appendicitis in children is required, including nuanced patient selection, longer term evaluation, the place of choice, and the acceptability of the treatment for children and their carers.