儿童无并发性尾炎的非手术治疗:一项随机,受控,非劣势性研究,评估安全性和有效性
Susan Elizabeth Adams1,2, Meegodage Roshell Swindri Perera2, Saskia Fung2
1Toby Bowring Department of Paediatric Surgery, Sydney Children's Hospital, Sydney, New South Wales, Australia.
ANZ journal of surgery
|June 14, 2024
概括
儿童简单尾炎的非手术治疗 (NOM) 没有被发现与手术治疗相比不劣. 然而,NOM是安全的,没有增加的并发症,需要进一步的研究,以精确患者选择.
科学领域:
- 儿科手术 儿科手术
- 临床试验 临床试验
- 胃肠道手术 胃肠道手术
背景情况:
- 尾炎是儿童最常见的手术紧急情况.
- 成人研究表明,非手术性管理 (NOM) 可能是可行的.
- 儿童尾炎 (NOM) 缺乏充足的随机对照试验.
研究的目的:
- 评估儿科简单尾炎非手术治疗 (NOM) 的安全性和有效性.
主要方法:
- 一项非劣势随机对照试验将手术管理 (OM) 与NOM进行比较,用于5至15岁儿童的简单尾炎.
- 主要结局是30天和12个月的治疗成功,定义为没有意外手术或并发症.
- 确定了15%的非劣势差额.
主要成果:
- 222名儿童被随机分配 (94名为OM,128名为NOM).
- 没有证明NOM的非劣势性;45.67%的NOM患者需要随后的手术.
- 在OM和NOM组之间没有观察到并发症率的显著差异.
结论:
- 与手术治疗相比,儿科简单尾炎的非手术治疗 (NOM) 不符合非劣质标准.
- 发现NOM是安全的,并发症率与操作管理相比较.
- 需要进一步的研究来定义NOM的作用,包括患者选择和长期结果.
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