Justin B Mahida1, Daniel L Lodwick1, Kristine M Nacion2, Jason P Sulkowski1, Karen L Leonhart2, Jennifer N Cooper2, Erica J Ambeba2, Katherine J Deans1, Peter C Minneci3. 1. Center for Surgical Outcomes Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH; Department of Surgery, Nationwide Children's Hospital, Columbus, OH. 2. Center for Surgical Outcomes Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH. 3. Center for Surgical Outcomes Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH; Department of Surgery, Nationwide Children's Hospital, Columbus, OH. Electronic address: Peter.Minneci@nationwidechildrens.org.
Abstract
BACKGROUND: The 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 DESIGN: We 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. RESULTS: Recruitment 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. CONCLUSIONS: Nonoperative management of acute appendicitis with an appendicolith in children resulted in an unacceptably high failure rate.
BACKGROUND: The 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 DESIGN: We 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. RESULTS: Recruitment 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. CONCLUSIONS: Nonoperative management of acute appendicitis with an appendicolith in children resulted in an unacceptably high failure rate.
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