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机械和口服抗生素的肠道制备与没有肠道制备用于选择性切除术 (MOBILE):多中心,随机,并行,单盲试验
Laura Koskenvuo1, Taru Lehtonen1, Selja Koskensalo1
1Department of Gastroenterological Surgery, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Lancet (London, England)
|August 13, 2019
概括
与没有肠道制备 (NBP) 相比,机械和口服抗生素肠道制备 (MOABP) 不会减少手术部位感染 (SSI) 或结肠手术中的病率. 根据这些发现,应重新考虑目前在切除术中使用MOABP的建议.
科学领域:
- 大肠直肠手术
- 预防手术感染
- 胃肠道手术
背景情况:
- 建议在结肠手术中使用机械和口服抗生素制备剂 (MOABP),以减少手术部位感染和发病率.
- 支持常规MOABP的证据是基于先前的研究,促使在前性随机试验中进行调查.
研究的目的:
- 评估MOABP与没有肠道制备 (NBP) 的有效性,以减少选择性结肠切除患者的SSI和整体发病率.
- 在结肠外科手术中挑战现有的MOABP建议.
主要方法:
- 进行了一项多中心,并行,单盲随机对照试验,涉及接受结肠切除的患者.
- 患者被随机分配 (1:1) 接受MOABP或NBP,所有参与人员的分配被掩盖.
- 主要结局是30天内SSI,使用修改的治疗意向方法进行分析.
主要成果:
- 在修改后的治疗意向分析中,共包括396名患者 (MOABP为196名,NBP为200名).
- 在MOABP组中,SSI的发生率为7%,而在NBP组中为11% (p=0. 17),没有显著的统计差异.
- 在两组中,瘤消亡和重复手术的发生率相似;在NBP组中发生了两例死亡,在MOABP组中没有死亡.
结论:
- 与没有肠道制备 (NBP) 相比,机械和口服抗生素肠道制备 (MOABP) 没有显著减少手术部位感染 (SSI) 或整体发病率.
- 这些发现表明,应重新评估常规MOABP在切除术中的建议.
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