Evgeny Rybakov1, Marat Nagudov2, Marina Sukhina2, Yuri Shelygin2,3. 1. Ryzhikh National Medical Research Center of Coloproctology, Saliama Adila 2, 123423, Moscow, Russia. erybakov@gmail.com. 2. Ryzhikh National Medical Research Center of Coloproctology, Saliama Adila 2, 123423, Moscow, Russia. 3. Russian Medical Academy of Continuous Professional Education, Moscow, Russia.
Abstract
AIM: To evaluate the impact of oral antibiotic prophylaxis on surgical site infection (SSI) rateafter 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.
RCT Entities:
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.
Authors: Martin Hübner; Michele Diana; Giorgio Zanetti; Marie-Christine Eisenring; Nicolas Demartines; Nicolas Troillet Journal: Arch Surg Date: 2011-07-18
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