BACKGROUND: The usefulness of preoperative oral antibiotics for the prevention of surgical site infection in elective colorectal surgery remains controversial.
OBJECTIVE: This study aimed to investigate the effects of oral antimicrobial prophylaxis in addition to intravenous antimicrobial prophylaxis on patients with ulcerative colitis undergoing restorative proctocolectomy.
DESIGN: This study was a randomized, nonblinded, single-center clinical trial.
SETTING: This study was conducted between July 1, 2006, and April 30, 2009, at Hyogo College of Medicine.
PATIENTS: Two hundred patients with ulcerative colitis scheduled to undergo restorative proctocolectomy with IPAA with an open approach were randomly assigned to either group A or B (n = 100). Combined use of preoperative oral antibiotics and intravenous antimicrobial prophylaxis were given to group A, and intravenous antimicrobial prophylaxis alone was given to group B.
INTERVENTIONS: Patients in group A received oral antibiotics the day before surgery (500 mg of kanamycin and 500 mg of metronidazole at 2:00 P.M., 3:00 P.M., and 9:00 P.M.), whereas those in group B did not. All patients underwent preoperative mechanical bowel preparation, and intravenous antimicrobial prophylaxis with second-generation cephalosporin was given for 24 hours.
MAIN OUTCOME MEASURES: The primary end point of this study was the incidence of overall surgical site infection according to intention-to-treat analysis.
RESULTS: The incidence of overall surgical site infection was significantly lower in group A (6/97 patients, 6.1%) than in group B (22/98 patients, 22.4%) (p = 0.0024). In multivariate analysis, the administration of oral antibiotics (OR, 0.178; 95% CI, 0.057–0.552; p = 0.003) and ASA score ≥3 (OR, 5.343; 95% CI, 1.595–17.891; p = 0.007) were independent risk factors for surgical site infection.
LIMITATIONS: This study is limited because of its open-label nature.
CONCLUSIONS: Combined oral and intravenous antimicrobial prophylaxis in patients with ulcerative colitis undergoing restorative proctocolectomy with IPAA contributed to the prevention of surgical site infection.