St Peter, Shawn D. and Noel-MacDonnell, Janelle R. and Hall, Nigel J. and Eaton, Simon and Suominen, Janne S. and Wester, Tomas and Svensson, Jan F. and Almstrom, Markus and Muenks, E. Pete and Beaudin, Marianne and Piche, Nelson and Brindle, Mary and MacRobie, Ali and Keijzer, Richard and Lilja, Helene Engstrand and Kassa, Ann-Marie and Jancelewicz, Tim and Butter, Andreana and Davidson, Jacob and Skarsgard, Erik and Te-Lu, Yap and Nah, Shireen and Willan, Andrew R. and Pierro, Agostino (2025) Appendicectomy versus antibiotics for acute uncomplicated appendicitis in children: An open-label, international, multicentre, randomised, non-inferiority trial. Lancet, 405 (10474). pp. 233-240. ISSN 0140-6736, DOI https://doi.org/10.1016/S0140-6736(24)02420-6.
Full text not available from this repository.Abstract
Background Support for the treatment of uncomplicated appendicitis with non-operative management rather than surgery has been increasing in the literature. We aimed to investigate whether treatment of uncomplicated appendicitis with antibiotics in children is inferior to appendicectomy by comparing failure rates for the two treatments. Methods In this pragmatic, multicentre, parallel-group, unmasked, randomised, non-inferiority trial, children aged 5-16 years with suspected non-perforated appendicitis (based on clinical diagnosis with or without radiological diagnosis) were recruited from 11 children's hospitals in Canada, the USA, Finland, Sweden, and Singapore. Patients were randomly assigned (1:1) to the antibiotic or the appendicectomy group with an online stratified randomisation tool, with stratification by sex, institution, and duration of symptoms (>= 48 h vs <48 h). The primary outcome was treatment failure within 1 year of random assignment. In the antibiotic group, failure was defined as removal of the appendix, and in the appendicectomy group, failure was defined as a normal appendix based on pathology. In both groups, failure was also defined as additional procedures related to appendicitis requiring general anaesthesia. Interim analysis was done to determine whether inferiority was to be declared at the halfway point. We used a non-inferiority design with a margin of 20%. All outcomes were assessed in participants with 12-month follow-up data. The trial was registered at ClinicalTrials.gov (NCT02687464). Findings Between Jan 20, 2016, and Dec 3, 2021, 936 patients were enrolled and randomly assigned to appendicectomy (n=459) or antibiotics (n=477). At 12-month follow-up, primary outcome data were available for 846 (90%) patients. Treatment failure occurred in 153 (34%) of 452 patients in the antibiotic group, compared with 28 (7%) of 394 in the appendicectomy group (difference 26.7%, 90% CI 22.4-30.9). All but one patient meeting the definition for treatment failure with appendicectomy were those with negative appendicectomies. Of those who underwent appendicectomy in the antibiotic group, 13 (8%) had normal pathology. There were no deaths or serious adverse events in either group. The relative risk of having a mild-to-moderate adverse event in the antibiotic group compared with the appendicectomy group was 4.3 (95% CI 2.1-8.7; p<0.0001). Interpretation Based on cumulative failure rates and a 20% non-inferiority margin, antibiotic management of non-perforated appendicitis was inferior to appendicectomy.
| Item Type: | Article |
|---|---|
| Funders: | Swedish Research Council, Academic Medical Organisation of Southwestern Ontario |
| Uncontrolled Keywords: | Nonoperative; Management; Meta analysis; Out come; Surgery; Safe |
| Subjects: | R Medicine > R Medicine (General) |
| Divisions: | Faculty of Medicine |
| Depositing User: | Ms. Juhaida Abd Rahim |
| Date Deposited: | 18 Sep 2025 08:39 |
| Last Modified: | 18 Sep 2025 08:39 |
| URI: | http://eprints.um.edu.my/id/eprint/48004 |
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