Abstract Background Guidelines recommending antibiotic prophylaxis at emergency cholecystectomy for cholecystitis were based on low-quality evidence. The aim of this trial was to demonstrate that omitting antibiotics is not inferior to their prophylactic use. Methods This multicentre, randomized, open-label, non-inferiority clinical trial randomly assigned adults with mild-to-moderate acute calculous cholecystitis (immediate cholecystectomy indicated) to 2 g cefazolin administered before incision or no antibiotic prophylaxis. The primary endpoint was a composite of all postoperative infectious complications in the first 30 days after surgery. Secondary endpoints included all individual components of the primary endpoint, other morbidity, and duration of hospital stay. Results Sixteen of 226 patients (7.1 per cent) in the single-dose prophylaxis group and 29 of 231 (12.6 per cent) in the no-prophylaxis group developed postoperative infectious complications (absolute difference 5.5 (95 per cent c.i. −0.4 to 11.3) per cent). With a non-inferiority margin of 10 per cent, non-inferiority of no prophylaxis was not proven. The number of surgical-site infections was significantly higher in the no-prophylaxis group (5.3 versus 12.1 per cent; P = 0.010). No differences were observed in the number of other complications, or duration of hospital stay. Conclusion Omitting antibiotic prophylaxis is not recommended.

中文翻译：

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急性胆囊切除术的抗生素预防：PEANUTS II 多中心随机非劣效性临床试验

摘要 背景建议在紧急胆囊切除术治疗胆囊炎时使用抗生素预防的指南是基于低质量的证据。该试验的目的是证明省略抗生素并不比预防性使用抗生素逊色。 方法这项多中心、随机、开放标签、非劣效性临床试验将患有轻至中度急性结石性胆囊炎（需要立即行胆囊切除术）的成人随机分配到切开前服用 2 g 头孢唑林或不使用抗生素预防。主要终点是术后前 30 天内所有术后感染并发症的综合。次要终点包括主要终点的所有单独组成部分、其他发病率和住院时间。 结果单剂量预防组的 226 名患者中有 16 名（7.1%）和无预防组的 231 名患者中有 29 名（12.6%）出现术后感染并发症（绝对差值 5.5（95% ci -0.4 至 11.3）/分）。由于非劣效性幅度为 10%，未证明不进行预防的非劣效性。未预防​​组的手术部位感染数量显着较高（5.3% vs 12.1%；P = 0.010）。其他并发症的数量或住院时间没有观察到差异。 结论不建议忽略抗生素预防。