Prophylactic treatment with oral antibiotics the day before elective colon surgery reduced the incidence of surgical site infections after surgery in patients with neoplasia or diverticular disease who did not undertake presurgical mechanical bowel preparation, according to study results published in The Lancet Gastroenterology and Hepatology.
Investigators with the multicenter, pragmatic, randomized controlled ORALEV trial (ClinicalTrails.gov identifier: NCT02505581) evaluated patients with a diagnosis of neoplasia or diverticular disease (median age, 71 years; interquartile range 63-79) who were indicated for either a partial colon resection or total colectomy. Participants were randomly assigned to either receive oral antibiotics the day prior to surgery (n=267) or to not receive prophylactic oral antibiotic treatment before surgery (n=269).
Neither group underwent mechanical bowel preparation. Patients assigned to receive oral antibiotics received 2 doses of 750 mg ciprofloxacin every 12 hours and 3 doses of 250 mg metronidazole every 8 hours the day prior to surgery. Intravenous 1.5 g cefuroxime and 1 g metronidazole were administered to all patients at time of anesthetic induction. The incidence of surgical site infections — defined as the sum of skin superficial, deep incisional, and organ-space infections — was the primary outcome. The investigators followed patients for up to 1 month after surgery.
A significantly greater incidence of surgical-site infections was observed in the control group compared with those who received oral antibiotics (11% vs 5%, respectively; P =.013). Compared with those who received no prophylactic antibiotic treatment, administration of oral antibiotics the day before colon surgery was associated with a significant reduction in the risk of surgical-site infections (odds ratio, 0.41; 95% CI, 0.20-0.80; P =.008).
Significantly more complications, including surgical-site infections, occurred in patients who did not receive oral antibiotics the day prior to surgery (28% vs 19%; P =.017). The investigators found no differences between the antibiotics group and the control group regarding local complications (7% vs 7%, respectively; treatment difference, 0.05; P =1.0), surgical complications (10% vs 15%; treatment difference, -4.75; P =.13), or medical complications (8% vs 10%; treatment difference, -1.80; P =.57).
Study limitations included the lack of a placebo for the control group, the investigators’ inability to blind surgeons and patients to the assigned treatment groups, and the exclusion of patients with inflammatory bowel disease to reduce the possibility of bias due to concomitant medication treatment.
”Our study is consistent with many others that indicate the use of oral antibiotics in the context of mechanical bowel preparation,” the researchers concluded. “Together with previous evidence, our study suggests that surgeons should implement oral antibiotics when preparing patients for elective colon surgery.”
Espin Basany E, Solís-Peña A, Pellino G, et al. Preoperative oral antibiotics and surgical-site infections in colon surgery (ORALEV): a multicentre, single-blind, pragmatic, randomised controlled trial. Lancet Gastroenterol Hepatol. 2020;5(8):729-738.