1 Department of Surgery, Hyogo College of Medicine, Mukogawa-cho, Nishinomiya-shi, Hyogo, Japan 2 Department of Infection Control and Prevention, Hyogo College of Medicine, Mukogawa-cho, Nishinomiya-shi, Hyogo, Japan.
Dis Colon Rectum. 2013 Oct;56(10):1149-55. doi: 10.1097/DCR.0b013e31829f71a0.
The usefulness of preoperative oral antibiotics for the prevention of surgical site infection in elective colorectal surgery remains controversial.
This study aimed to investigate the effects of oral antimicrobial prophylaxis in addition to intravenous antimicrobial prophylaxis on patients with ulcerative colitis undergoing restorative proctocolectomy.
This study was a randomized, nonblinded, single-center clinical trial.
This study was conducted between July 1, 2006, and April 30, 2009, at Hyogo College of Medicine.
Two hundred patients with ulcerative colitis scheduled to undergo restorative proctocolectomy with IPAA with an open approach were randomly assigned to either group A or B (n = 100). Combined use of preoperative oral antibiotics and intravenous antimicrobial prophylaxis were given to group A, and intravenous antimicrobial prophylaxis alone was given to group B.
Patients in group A received oral antibiotics the day before surgery (500 mg of kanamycin and 500 mg of metronidazole at 2:00 P.M., 3:00 P.M., and 9:00 P.M.), whereas those in group B did not. All patients underwent preoperative mechanical bowel preparation, and intravenous antimicrobial prophylaxis with second-generation cephalosporin was given for 24 hours.
The primary end point of this study was the incidence of overall surgical site infection according to intention-to-treat analysis.
The incidence of overall surgical site infection was significantly lower in group A (6/97 patients, 6.1%) than in group B (22/98 patients, 22.4%) (p = 0.0024). In multivariate analysis, the administration of oral antibiotics (OR, 0.178; 95% CI, 0.057-0.552; p = 0.003) and ASA score ≥3 (OR, 5.343; 95% CI, 1.595-17.891; p = 0.007) were independent risk factors for surgical site infection.
This study is limited because of its open-label nature.
Combined oral and intravenous antimicrobial prophylaxis in patients with ulcerative colitis undergoing restorative proctocolectomy with IPAA contributed to the prevention of surgical site infection.
择期结直肠手术中,术前口服抗生素预防手术部位感染的效果仍存在争议。
本研究旨在探讨在接受回肠贮袋肛管吻合术的溃疡性结肠炎患者中,除静脉用抗生素外,加用口服抗生素预防的效果。
这是一项随机、非盲、单中心临床试验。
本研究于 2006 年 7 月 1 日至 2009 年 4 月 30 日在兵库医科大学进行。
200 例溃疡性结肠炎患者,计划接受开放式回肠贮袋肛管吻合术,将患者随机分配至 A 组或 B 组(n = 100)。A 组患者术前 1 天接受口服抗生素(下午 2 点、3 点和 9 点给予 500 mg 卡那霉素和 500 mg 甲硝唑),B 组仅接受静脉用抗生素预防。
所有患者均接受术前机械肠道准备,并给予第二代头孢菌素静脉用抗生素预防 24 小时。
本研究的主要终点是根据意向治疗分析的总体手术部位感染发生率。
A 组(97 例患者中有 6 例,6.1%)的总体手术部位感染发生率显著低于 B 组(98 例患者中有 22 例,22.4%)(p = 0.0024)。多变量分析显示,口服抗生素的应用(OR,0.178;95%CI,0.057-0.552;p = 0.003)和美国麻醉医师协会(ASA)评分≥3 (OR,5.343;95%CI,1.595-17.891;p = 0.007)是手术部位感染的独立危险因素。
本研究由于其开放性标签设计而存在局限性。
溃疡性结肠炎患者在接受回肠贮袋肛管吻合术时,联合使用口服和静脉用抗生素预防有助于预防手术部位感染。