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Clinical Trial
High failure rate of nonoperative management of acute appendicitis with an appendicolith in children.
- Justin B Mahida, Daniel L Lodwick, Kristine M Nacion, Jason P Sulkowski, Karen L Leonhart, Jennifer N Cooper, Erica J Ambeba, Katherine J Deans, and Peter C Minneci.
- Center for Surgical Outcomes Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH; Department of Surgery, Nationwide Children's Hospital, Columbus, OH.
- J. Pediatr. Surg. 2016 Jun 1; 51 (6): 908-11.
BackgroundThe purpose of this study was to investigate the feasibility of nonoperative management of acute appendicitis in children with an appendicolith identified on preoperative imaging.Study DesignWe performed a prospective nonrandomized trial of nonoperative management of uncomplicated acute appendicitis with an appendicolith in children aged 7 to 17years. The primary outcome was the failure rate of nonoperative management, defined as having undergone an appendectomy. Early termination was set to occur if the lower limit of the 95% confidence interval of the failure rate was greater than 20% at 30days or 30% at 1year.ResultsRecruitment for this study was halted after enrollment of 14 patients (N=5 nonoperative; N=9 surgery). The failure rate of nonoperative management was 60% (3/5) at a median follow-up of 4.7months (IQR 1.0-7.6) with a 95% CI of 23%-88%. None of the three patients that failed nonoperative management had complicated appendicitis at the time of appendectomy, while six out of nine patients who chose surgery had complicated appendicitis (0/3 vs. 6/9, p=0.18). The trial was stopped for concerns over patient safety.ConclusionsNonoperative management of acute appendicitis with an appendicolith in children resulted in an unacceptably high failure rate.Copyright © 2016 Elsevier Inc. All rights reserved.
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