Mahida Justin B, Lodwick Daniel L, Nacion Kristine M, Sulkowski Jason P, Leonhart Karen L, Cooper Jennifer N, Ambeba Erica J, Deans Katherine J, Minneci Peter C
Center for Surgical Outcomes Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH; Department of Surgery, Nationwide Children's Hospital, Columbus, OH.
Center for Surgical Outcomes Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH.
J Pediatr Surg. 2016 Jun;51(6):908-11. doi: 10.1016/j.jpedsurg.2016.02.056. Epub 2016 Mar 2.
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.
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.
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.
Nonoperative management of acute appendicitis with an appendicolith in children resulted in an unacceptably high failure rate.
本研究的目的是探讨对术前影像学检查发现阑尾结石的儿童急性阑尾炎进行非手术治疗的可行性。
我们对7至17岁患有阑尾结石的单纯性急性阑尾炎儿童进行了非手术治疗的前瞻性非随机试验。主要结局是非手术治疗的失败率,定义为接受阑尾切除术。如果失败率的95%置信区间下限在30天时大于20%或在1年时大于30%,则设定提前终止试验。
在纳入14例患者后(非手术组N = 5;手术组N = 9),本研究停止招募。非手术治疗的失败率为60%(3/5),中位随访时间为4.7个月(四分位间距1.0 - 7.6),95%置信区间为23% - 88%。非手术治疗失败的3例患者在阑尾切除时均无复杂性阑尾炎,而选择手术的9例患者中有6例患有复杂性阑尾炎(0/3 vs. 6/9,p = 0.18)。由于对患者安全的担忧,试验停止。
对患有阑尾结石的儿童急性阑尾炎进行非手术治疗导致失败率高得令人无法接受。