Randomized Clinical Trial Comparing Intravenous Antimicrobial Prophylaxis Alone with Oral and Intravenous Antimicrobial Prophylaxis for the Prevention of a Surgical Site Infection in Colorectal Cancer Surgery

Abstract

The use of preoperative oral antibiotics during preparation for elective colorectal surgery remains controversial. This was a prospective randomized clinical trial to compare the efficacy of intravenous antimicrobial prophylaxis alone with combined oral and intravenous antimicrobial prophylaxis for surgical site infection (SSI) in patients undergoing elective colorectal surgery. Five hundred patients were enrolled in this study. Of these, 491 were randomly assigned to receive either intravenous antimicrobial prophylaxis or combined oral and intravenous antimicrobial prophylaxis. The primary outcome was the incidence of SSI within 6 weeks of elective colorectal surgery. The incidence of SSI was similar in the two treatment groups: intravenous alone, 10.7%; and oral and intravenous, 7.0% (difference 3.7%; 95% confidence interval -4.8% to 5.6%). No critical adverse events were reported. The addition of oral antibiotics to intravenous antimicrobial prophylaxis showed no advantage in the prevention of SSI.