Impact of oral antibiotic prophylaxis on surgical site infection after rectal surgery: results of randomized trial

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ORIGINAL ARTICLE

Impact of oral antibiotic prophylaxis on surgical site infection after rectal surgery: results of randomized trial Evgeny Rybakov 1

&

Marat Nagudov 1 & Marina Sukhina 1 & Yuri Shelygin 1,2

Accepted: 8 September 2020 # Springer-Verlag GmbH Germany, part of Springer Nature 2020

Abstract Aim To evaluate the impact of oral antibiotic prophylaxis on surgical site infection (SSI) rate after rectal surgery. Methods It was a single-center 1:1 randomized controlled open parallel trial (registration number NCT03436719). The patients undergoing rectal resection for benign and malignant tumors were assigned randomly to two groups: the oral plus intravenous (IV) antibiotic prophylaxis (AP) and the IV antibiotic prophylaxis only. The primary endpoint was the overall rate of SSI. Results Between November 2017 and December 2018, 116 (male—55, the mean age—64 years) patients were enrolled into the trial. Of them, 57 had oral erythromycin 500 mg + metronidazole 500 mg a day before surgery and 1,000 mg of cephalosporin IV 30–90 min before operation. In the other group, 59 patients had the same IV antibiotics only. The incidence of SSIs was 22% (13/ 59) and 3.5% (2/57) correspondingly (р = 0.002). The statistically significant difference was detected for superficial SSI 0 (0%) vs. 5 (8.5%) (p = 0.03) and organ/space SSI 2 (3.5%) vs. 9 (15.3%) (p = 0.03), respectively. A multivariate analysis of risk factors of SSI identified two independent ones: bacterial contamination of the pelvic cavity ≥ 105 CFU at the end of surgery OR 17.9, 95% CI 2.1–150.0 (p = 0.008) and oral antimicrobial prophylaxis OR 0.2, 95% CI 0.03–0.8 (p = 0.02). Conclusion Oral-parenteral AP significantly reduced the risk of SSI following elective rectal surgery. Bacterial contamination of the pelvic cavity ≥ 105 CFU at the end of surgery and oral antimicrobial prophylaxis were independent risk factors of SSI. Keywords Mechanical bowel preparation . Oral antibiotics . Surgical site infection . Colorectal surgery

Introduction Surgical site infection (SSI) remains the most common problem of colorectal surgery. Arising in 11–26% of cases, SSI increases treatment costs due to prolonged postoperative hospital stay and necessity of antimicrobial therapy [1–3]. Since the first randomized clinical trial (RCT) published in 1965, preoperative systemic antimicrobial prophylaxis has become a standard management of patients after operations on large intestine [4]. An abstract of the study was presented as a Free Paper at the 14th Annual Meeting of European Society of Coloproctology on September 25–27th, 2019 in Vienna, Austria. * Evgeny Rybakov [email protected] 1

Ryzhikh National Medical Research Center of Coloproctology, Saliama Adila 2, 123423 Moscow, Russia

2

Russian Medical Academy of Continuous Professional Education, Moscow, Russia

Though the first studies of oral antibiotics for prevention of SSI appeared in the 1970s [5], the obtained results were confusing and ranged from a complete lack of effectiveness to a marked decrease in the SSI inciden