Preoperative Oral Antibiotics and Surgical Site Infections in Colon Surgery Without Mechanical Bowel Preparation. A Prospective, Multicentre, Single Blinded, Randomized Trial (ORALEV Study)

Abstract

Background: Previous studies have found that combined mechanical bowel preparation (MBP) and oral antibiotics (OAB) can reduce the rate of SSI, but no randomized controlled trial has evaluated OAB alone without MBP. The aim of this study was to determine whether prophylaxis with OAB the day before elective colon surgery influences the rate of surgical site infections (SSI) postoperatively. Methods: Randomized controlled multicenter trial at 5 major hospitals with the participation of 47 colorectal surgeons. Patients undergoing colon surgery were randomized into 2 groups, with and without administration of OAB (ciprofloxacin, metronidazole) the day before surgery. All patients received intra-venous antibiotics during surgery. Patients were followed up for 1 month and all postsurgical complications were registered. Findings: A total of 565 patients were randomized to receive either no treatment (n=269) or OAB (n=267). The rate of SSI in the No-OAB group (11.2%) was significantly higher than in the OAB group (4.9%) (p=0.013). OAB were associated with a significant risk reduction compared with No-OAB (OR=0.41, 95%CI=0.20-0.80, p=0.008). We found no statistically significant differences in the types of SSI observed in the two groups. Open surgery versus laparoscopy was an independent risk factor of SSI (OR=2.29, 95% CI=1.16-4.41, p=0.018). Interpretation: The administration of OAB as prophylaxis the day before colon surgery significantly reduces the rate of SSI without MBP and should be routinely adopted before elective colon surgery. Registration Information: The study was registered with EudraCT number 2014-002345-21 and ClinicalTrials.gov identifier NCT02505581. Funding Statement: This study was partly funded by a grant from the Fundacion Asociacion Espanola de Coloproctologia (FAECP). Declaration of Interests: The authors report no conflicts of interest. Ethics Approval Statement: All eligible patients provided written informed consent before undergoing study-related procedures. The study protocol was approved by the Ethics Commission of the Valle de Hebron University Hospital and conducted in accordance with the Declaration of Helsinki (World Medical Association, 2013).