Randomized clinical trial of extended versus single-dose perioperative antibiotic prophylaxis for acute calculous cholecystitis
Randomized clinical trial of extended versus single-dose perioperative antibiotic prophylaxis for acute calculous cholecystitis
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DOI：
10.1002/bjs.10406
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发表时间：
2017-01-01
影响因子：
9.6
通讯作者：
Boerma, D.
中科院分区：
文献类型：
--
作者：
Loozen, C. S.;Kortram, K.;Boerma, D.
背景许多急性胆囊炎手术患者接受术后抗生素预防，目的是减少感染并发症。然而，没有证据表明，延长抗生素超过一个围手术期剂量是有利的。本研究旨在确定延长抗生素预防对轻度急性胆囊炎患者接受胆囊切除术后感染并发症的影响。MethodsFor this randomized controlled non-inferior trial，2012年4月至2014年9月期间，对荷兰6家主要教学医院接受胆囊切除术的轻度急性结石性胆囊炎成人患者进行了资格评估。患者随机接受术前单剂量头孢唑林（2000 mg）或术后3天抗生素预防（静脉注射头孢呋辛750 mg+甲硝唑500 mg，每日3次）。主要终点是术后30天内感染并发症的发生率。结果在意向性治疗分析中，扩展抗生素组77例患者中有3例（4%）和标准预防组73例患者中有3例（4%）发生术后感染并发症（绝对差异02（95% c.i. -82%至89%）。基于5%的界值，标准预防与扩展预防相比的非劣效性未得到证实。平均住院时间为3天，在延长抗生素组和1天的标准prophylaxis group.ConclusionStandard单剂量抗生素预防并没有导致轻度急性胆囊炎行胆囊切除术患者术后感染并发症的增加。注册号：NTR 3089（www.trialregister.nl）。
BackgroundMany patients who have surgery for acute cholecystitis receive postoperative antibiotic prophylaxis, with the intent to reduce infectious complications. There is, however, no evidence that extending antibiotics beyond a single perioperative dose is advantageous. This study aimed to determine the effect of extended antibiotic prophylaxis on infectious complications in patients with mild acute cholecystitis undergoing cholecystectomy.MethodsFor this randomized controlled non-inferiority trial, adult patients with mild acute calculous cholecystitis undergoing cholecystectomy at six major teaching hospitals in the Netherlands, between April 2012 and September 2014, were assessed for eligibility. Patients were randomized to either a single preoperative dose of cefazolin (2000 mg), or antibiotic prophylaxis for 3 days after surgery (intravenous cefuroxime 750 mg plus metronidazole 500 mg, three times daily), in addition to the single dose. The primary endpoint was rate of infectious complications within 30 days after operation.ResultsIn the intention-to-treat analysis, three of 77 patients (4 per cent) in the extended antibiotic group and three of 73 (4 per cent) in the standard prophylaxis group developed postoperative infectious complications (absolute difference 02 (95 per cent c.i. -82 to 89) per cent). Based on a margin of 5 per cent, non-inferiority of standard prophylaxis compared with extended prophylaxis was not proven. Median length of hospital stay was 3 days in the extended antibiotic group and 1 day in the standard prophylaxis group.ConclusionStandard single-dose antibiotic prophylaxis did not lead to an increase in postoperative infectious complications in patients with mild acute cholecystitis undergoing cholecystectomy. Registration number: NTR3089 (www.trialregister.nl).