Ruangsin Sakchai, Laohawiriyakamol Supparerk, Sunpaweravong Somkiat, Mahattanobon Somrit
Department of Surgery, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, 90110, Thailand,
Surg Endosc. 2015 Apr;29(4):874-81. doi: 10.1007/s00464-014-3745-x. Epub 2014 Jul 23.
A prophylactic antibiotic is recommended in open cholecystectomy surgeries, but in laparoscopic cholecystectomies such prophylaxis is controversial. Recent reviews have not found conclusive evidence that routine prophylaxis, especially in low risk patients, is effective. This clinical trial was undertaken to evaluate the efficacy of cefazolin in reducing surgical site infection SSI in laparoscopic cholecystectomies in a sample not screened for high or low risk patients.
A randomized double-blind controlled trial was conducted in a single university hospital. Scheduled cholecystectomy patients without selection for patient risk factors were randomized into two groups. Pre-operatively, group A patients received a placebo of 10 ml isotonic sodium chloride, and group B patients received 1 g of cefazolin as a prophylactic antibiotic. All patients underwent a standard laparoscopic cholecystectomy, and were followed up for at least 30 days.
Two hundred ninety-nine patients were randomized (149 in group A and 150 in group B). SSI occurred in seven patients (2.34 %), five (1.67 %) in the placebo group, and two (0.67 %) in the prophylactic antibiotic group. The difference was not statistically significant (p value = 0.512), and no specific risk factors for post-operative infection were identified.
A single dose of preoperative prophylactic cefazolin has no significant benefit in reducing the incidence of SSI in laparoscopic cholecystectomy. Whether or not to use a prophylactic depends on the individual patient, and the consideration of the attending surgeon.
开腹胆囊切除术推荐使用预防性抗生素,但在腹腔镜胆囊切除术中这种预防措施存在争议。近期综述未找到确凿证据表明常规预防措施有效,尤其是在低风险患者中。本临床试验旨在评估头孢唑林在未筛选高风险或低风险患者的样本中,对降低腹腔镜胆囊切除术手术部位感染(SSI)的疗效。
在一家大学医院进行了一项随机双盲对照试验。未根据患者风险因素进行选择的预定胆囊切除术患者被随机分为两组。术前,A组患者接受10毫升等渗氯化钠安慰剂,B组患者接受1克头孢唑林作为预防性抗生素。所有患者均接受标准腹腔镜胆囊切除术,并随访至少30天。
299例患者被随机分组(A组149例,B组150例)。7例患者发生手术部位感染(2.34%),安慰剂组5例(1.67%),预防性抗生素组2例(0.67%)。差异无统计学意义(p值 = 0.512),未发现术后感染的特定风险因素。
术前单剂量预防性使用头孢唑林在降低腹腔镜胆囊切除术手术部位感染发生率方面无显著益处。是否使用预防性抗生素取决于个体患者以及主刀医生的考虑。