Loozen Charlotte S, van Santvoort Hjalmar C, van Geloven Antoinette A W, Nieuwenhuijzen Grard A P, de Reuver Philip R, Besselink Mark H G, Vlaminckx Bart, Kelder Johannes C, Knibbe Catherijne A J, Boerma Djamila
Department of Surgery, St. Antonius Hospital, Koekoekslaan 1, Postbus 2500, 3430 EM, Nieuwegein, The Netherlands.
Department of Surgery, Tergooi Hospital, Hilversum, The Netherlands.
Trials. 2017 Aug 23;18(1):390. doi: 10.1186/s13063-017-2142-x.
The additional value of perioperative antibiotic prophylaxis in preventing infectious complications after emergency cholecystectomy for acute cholecystitis is a much-debated subject in the surgical community. Evidence-based guidelines are lacking, and consequently the use of antibiotic prophylaxis varies greatly among surgeons and hospitals. Recently, high-level evidence became available demonstrating that postoperative antibiotic prophylaxis in patients with acute cholecystitis does not reduce the risk of infectious complications. Preoperative antibiotic prophylaxis in relation to the risk of infectious complications, however, has never been studied.
The PEANUTS II trial is a randomized, controlled, multicenter, open-label noninferiority trial whose aim is to determine the utility of preoperative antibiotic prophylaxis in patients undergoing emergency cholecystectomy for acute calculous cholecystitis. Patients with mild or moderate acute cholecystitis, as defined according the Tokyo Guidelines, will be randomly assigned to a single preoperative dose of antibiotic prophylaxis (2000 mg of first-generation cephalosporin delivered intravenously) or no antibiotic prophylaxis before emergency cholecystectomy. The primary endpoint is a composite endpoint consisting of all postoperative infectious complications occurring during the first 30 days after surgery. Secondary endpoints include all the individual components of the primary endpoint, all other complications, duration of hospital stay, and total costs. The hypothesis is that the absence of antibiotic prophylaxis is noninferior to the presence of antibiotic prophylaxis. A noninferiority margin of 10% is assumed. With a 1-sided risk of 2.5% and a power of 80%, a total of 454 subjects will have to be included. Analysis will be performed according to the intention-to-treat principle.
The PEANUTS II trial will provide evidence-based advice concerning the utility of antibiotic prophylaxis in patients undergoing emergency cholecystectomy for acute calculous cholecystitis.
Netherlands Trial Register, NTR5802 . Registered on 4 June 2016.
围手术期抗生素预防在预防急性胆囊炎急诊胆囊切除术后感染性并发症方面的附加价值，是外科界备受争议的话题。缺乏循证指南，因此抗生素预防的使用在外科医生和医院之间差异很大。最近，有高级证据表明，急性胆囊炎患者术后使用抗生素预防并不能降低感染性并发症的风险。然而，术前抗生素预防与感染性并发症风险的关系从未被研究过。
PEANUTS II试验是一项随机、对照、多中心、开放标签的非劣效性试验，其目的是确定术前抗生素预防在因急性结石性胆囊炎接受急诊胆囊切除术患者中的效用。根据东京指南定义的轻度或中度急性胆囊炎患者，将被随机分配接受单次术前抗生素预防（静脉注射2000毫克第一代头孢菌素）或在急诊胆囊切除术前不进行抗生素预防。主要终点是一个复合终点，包括术后30天内发生的所有术后感染性并发症。次要终点包括主要终点的所有个体组成部分、所有其他并发症、住院时间和总成本。假设是不进行抗生素预防不劣于进行抗生素预防。假定非劣效界值为10%。单侧风险为2.5%，检验效能为80%，总共需要纳入454名受试者。将根据意向性分析原则进行分析。
PEANUTS II试验将为因急性结石性胆囊炎接受急诊胆囊切除术患者的抗生素预防效用提供循证建议。
荷兰试验注册库，NTR5802。于2016年6月4日注册。
