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

Autor: Adams SE; Toby Bowring Department of Paediatric Surgery, Sydney Children's Hospital, Sydney, New South Wales, Australia.; Discipline of Paediatrics, School of Clinical Medicine, Faculty of Medicine and Health, University of New South Wales, Sydney, New South Wales, Australia., Perera MRS; Discipline of Paediatrics, School of Clinical Medicine, Faculty of Medicine and Health, University of New South Wales, Sydney, New South Wales, Australia., Fung S; Discipline of Paediatrics, School of Clinical Medicine, Faculty of Medicine and Health, University of New South Wales, Sydney, New South Wales, Australia., Maxton J; Discipline of Paediatrics, School of Clinical Medicine, Faculty of Medicine and Health, University of New South Wales, Sydney, New South Wales, Australia., Karpelowsky J; Discipline of Paediatrics, School of Clinical Medicine, Faculty of Medicine and Health, University of New South Wales, Sydney, New South Wales, Australia.; Department of Paediatric Surgery, Children's Hospital at Westmead, Sydney, New South Wales, Australia.; Discipline of Child and Adolescent Health, Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.
Jazyk: angličtina
Zdroj: ANZ journal of surgery [ANZ J Surg] 2024 Sep; Vol. 94 (9), pp. 1569-1577. Date of Electronic Publication: 2024 Jun 14.
DOI: 10.1111/ans.19119
Abstrakt: 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.
(© 2024 The Author(s). ANZ Journal of Surgery published by John Wiley & Sons Australia, Ltd on behalf of Royal Australasian College of Surgeons.)
Databáze: MEDLINE
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