Background

Previous studies have found that mechanical bowel preparation with oral antibiotics can reduce the incidence of surgical-site infections, but no randomised controlled trial has assessed oral antibiotics alone without mechanical bowel preparation. The aim of this study was to determine whether prophylaxis with oral antibiotics the day before elective colon surgery affects the incidence of postoperative surgical-site infections.

Methods

In this multicentre, pragmatic, randomised controlled trial (ORALEV), patients undergoing colon surgery were recruited from five major hospitals in Spain and 47 colorectal surgeons at these hospitals participated. Patients were eligible for inclusion if they were diagnosed with neoplasia or diverticular disease and if a partial colon resection or total colectomy was indicated. Participants were randomly assigned (1:1) using online randomisation tables to either administration of oral antibiotics the day before surgery (experimental group) or no administration of oral antibiotics before surgery (control group). For the experimental group, ciprofloxacin 750 mg was given every 12 h (two doses at 1200 h and 0000 h) and metronidazole 250 mg every 8 h (three doses at 1200 h, 1800 h, and 0000 h) the day before surgery. All patients were given intravenous cefuroxime 1·5 g and metronidazole 1 g at the time of anaesthetic induction. The primary outcome was incidence of surgical-site infections. Patients were followed up for 1 month after surgery and all postsurgical complications were registered. This study was registered with EudraCT, 2014-002345-21, and ClinicalTrials.gov, NCT02505581, and is closed to accrual.

Findings

Between May 2, 2015, and April 15, 2017, we assessed 582 patients for eligibility, of whom 565 were eligible and randomly assigned to receive either no oral antibiotics (n=282) or oral antibiotics (n=282) before surgery. 13 participants in the control group and 16 in the experimental group were subsequently excluded; 269 participants in the control group and 267 in the experimental group received their assigned intervention. The incidence of surgical-site infections in the control group (30 [11%] of 269) was significantly higher than in the experimental group (13 [5%] of 267; χ² test p=0·013). Oral antibiotics were associated with a significant reduction in the risk of surgical-site infections compared with no oral antibiotics (odds ratio 0·41, 95% CI 0·20–0·80; p=0·008). More complications (including surgical-site infections) were observed in the control group than in the experimental group (76 [28%] vs 51 [19%]; p=0·017), although there was no difference in severity as assessed by Clavien-Dindo score. No differences were noted between groups in terms of local complications, surgical complications, or medical complications that were not related to septic complications.

Interpretation

The administration of oral antibiotics as prophylaxis the day before colon surgery significantly reduces the incidence of surgical-site infections without mechanical bowel preparation and should be routinely adopted before elective colon surgery.

Funding

Fundación Asociación Española de Coloproctología.

中文翻译：

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结肠手术中的术前口服抗生素和手术部位感染（ORALEV）：一项多中心，单盲，实用，随机对照试验。

背景

先前的研究发现，口服抗生素的机械肠道准备可以降低手术部位感染的发生率，但是没有一项随机对照试验评估没有口服机械肠道准备的口服抗生素。这项研究的目的是确定选择性结肠手术前一天口服抗生素的预防措施是否会影响术后手术部位感染的发生率。

方法

在这项多中心，实用，随机对照试验（ORALEV）中，从西班牙的五家主要医院招募了接受结肠手术的患者，这些医院的47名结直肠外科医师参加了该研究。如果患者被诊断出患有肿瘤或憩室病，并且需要进行部分结肠切除或完全结肠切除术，则符合纳入条件。使用在线随机表将参与者随机分配（1：1），以在手术前一天给予口服抗生素（实验组）或在手术前不给予口服抗生素（对照组）。对于实验组，在手术前一天每12小时（分别在1200 h和0000 h服用两次）分别给予750 mg环丙沙星和每8 h（在1200 h，1800 h和0000 h服用3次）的甲硝唑250 mg。麻醉诱导时，所有患者均接受静脉注射头孢呋辛1·5 g和甲硝唑1 g。主要结果是手术部位感染的发生率。手术后对患者进行了1个月的随访，并记录了所有术后并发症。该研究已在EudraCT（2014-002345-21）和ClinicalTrials.gov（NCT02505581）进行了注册，目前尚未公开。

发现

在2015年5月2日至2017年4月15日之间，我们评估了582例患者的资格，其中565例合格并随机分配在手术前不接受口服抗生素（n = 282）或口服抗生素（n = 282）。随后排除了对照组的13名参与者和实验组的16名参与者；对照组中有269名参与者，实验组中有267名参与者接受了分配的干预措施。（269 30 [11％]）在对照组中手术部位感染的发生率明显高于在267实验组（13 [5％]显著更高;χ ²测试p = 0·013）。与不口服抗生素相比，口服抗生素与减少手术部位感染的风险有关（赔率比0·41，95％CI 0·20-0·80； p = 0·008）。对照组观察到的并发症（包括手术部位感染）比实验组更多（76 [28％] vs 51 [19％]； p = 0·017），尽管严重程度没有差异。 Clavien-Dindo得分。在局部并发症，手术并发症或与脓毒症并发症无关的医学并发症方面，两组之间未发现差异。

解释

结肠手术前一天预防口服口服抗生素可显着降低无需机械肠道准备的手术部位感染的发生率，因此应在选择性结肠手术之前常规采用。

资金

西班牙语基金会。