Importance Nonoperative management with antibiotics alone has the potential to treat uncomplicated pediatric appendicitis with fewer disability days than surgery. Objective To determine the success rate of nonoperative management and compare differences in treatment-related disability, satisfaction, health-related quality of life, and complications between nonoperative management and surgery in children with uncomplicated appendicitis. Design, Setting, and Participants Multi-institutional nonrandomized controlled intervention study of 1068 children aged 7 through 17 years with uncomplicated appendicitis treated at 10 tertiary children's hospitals across 7 US states between May 2015 and October 2018 with 1-year follow-up through October 2019. Of the 1209 eligible patients approached, 1068 enrolled in the study. Interventions Patient and family selection of nonoperative management with antibiotics alone (nonoperative group, n = 370) or urgent (≤12 hours of admission) laparoscopic appendectomy (surgery group, n = 698). Main Outcomes and Measures The 2 primary outcomes assessed at 1 year were disability days, defined as the total number of days the child was not able to participate in all of his/her normal activities secondary to appendicitis-related care (expected difference, 5 days), and success rate of nonoperative management, defined as the proportion of patients initially managed nonoperatively who did not undergo appendectomy by 1 year (lowest acceptable success rate, ≥70%). Inverse probability of treatment weighting (IPTW) was used to adjust for differences between treatment groups for all outcome assessments. Results Among 1068 patients who were enrolled (median age, 12.4 years; 38% girls), 370 (35%) chose nonoperative management and 698 (65%) chose surgery. A total of 806 (75%) had complete follow-up: 284 (77%) in the nonoperative group; 522 (75%) in the surgery group. Patients in the nonoperative group were more often younger (median age, 12.3 years vs 12.5 years), Black (9.6% vs 4.9%) or other race (14.6% vs 8.7%), had caregivers with a bachelor's degree (29.8% vs 23.5%), and underwent diagnostic ultrasound (79.7% vs 74.5%). After IPTW, the success rate of nonoperative management at 1 year was 67.1% (96% CI, 61.5%-72.31%; P = .86). Nonoperative management was associated with significantly fewer patient disability days at 1 year than did surgery (adjusted mean, 6.6 vs 10.9 days; mean difference, -4.3 days (99% CI, -6.17 to -2.43; P < .001). Of 16 other prespecified secondary end points, 10 showed no significant difference. Conclusion and Relevance Among children with uncomplicated appendicitis, an initial nonoperative management strategy with antibiotics alone had a success rate of 67.1% and, compared with urgent surgery, was associated with statistically significantly fewer disability days at 1 year. However, there was substantial loss to follow-up, the comparison with the prespecified threshold for an acceptable success rate of nonoperative management was not statistically significant, and the hypothesized difference in disability days was not met. Trial Registration ClinicalTrials.gov Identifier: NCT02271932.

中文翻译：

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使用抗生素治疗与腹腔镜阑尾切除术的非手术治疗与无并发症性阑尾炎儿童治疗成功和残疾天数的关系


重要性 单独使用抗生素进行非手术治疗有可能治疗无并发症的小儿阑尾炎，且残疾天数比手术更少。目的 确定无并发症性阑尾炎儿童非手术治疗的成功率，并比较非手术治疗与手术治疗相关残疾、满意度、健康相关生活质量和并发症的差异。设计、背景和参与者 2015 年 5 月至 2018 年 10 月期间，对美国 7 个州的 10 家三级儿童医院治疗的 1068 名 7 至 17 岁无并发症阑尾炎儿童进行的多机构非随机对照干预研究，并随访至 2019 年 10 月为期一年在 1209 名符合条件的患者中，有 1068 名参加了该研究。干预措施 患者和家属选择仅使用抗生素的非手术治疗（非手术组，n = 370）或紧急（入院 12 小时内）腹腔镜阑尾切除术（手术组，n = 698）。主要成果和措施 1 年时评估的 2 个主要成果是残疾天数，定义为儿童因阑尾炎相关护理而无法参加所有正常活动的总天数（预期差异，5 天） ）和非手术治疗的成功率，定义为最初非手术治疗的患者在 1 年内未接受阑尾切除术的比例（可接受的最低成功率，≥70%）。使用治疗加权逆概率（IPTW）来调整所有结果评估的治疗组之间的差异。结果 在 1068 名入组患者中（中位年龄 12.4 岁；38% 为女孩），370 名 (35%) 名患者选择非手术治疗，698 名 (65%) 名患者选择手术治疗。 共有 806 例（75%）完成了随访：非手术组 284 例（77%）；手术组中有 522 人（75%）。非手术组的患者通常更年轻（中位年龄为 12.3 岁 vs 12.5 岁）、黑人（9.6% vs 4.9%）或其他种族（14.6% vs 8.7%），护理人员拥有学士学位（29.8% vs 23.5%）。 %），并接受超声诊断（79.7% vs 74.5%）。 IPTW 后，1 年时非手术治疗的成功率为 67.1%（96% CI，61.5%-72.31%；P = .86）。与手术治疗相比，非手术治疗与 1 年时患者残疾天数显着减少相关（调整后平均值为 6.6 天与 10.9 天；平均差异为 -4.3 天（99% CI，-6.17 至 -2.43；P < .001）。 16与其他预先指定的次要终点相比，10 项显示无显着差异 结论和相关性 在无并发症阑尾炎的儿童中，仅使用抗生素的初始非手术治疗策略的成功率为 67.1%，并且与紧急手术相比，其残疾率在统计学上显着减少。然而，随访损失很大，与预先设定的可接受的非手术治疗成功率阈值的比较没有统计学意义，并且未达到试验注册临床试验中假设的残疾天数差异。政府标识符：NCT02271932。