Efficacy of Preoperative Oral Antibiotic Prophylaxis for the Prevention of Surgical Site Infections in Patients With Crohn Disease: A Randomized Controlled Trial.

Objectives: We investigated the efficacy of oral antimicrobial prophylaxis in patients undergoing surgery for Crohn disease.

Background: Although oral antibiotic prophylaxis with mechanical bowel preparation has been recommended for colorectal surgery, the use of this approach remains somewhat controversial. Moreover, the efficacy of this approach for inflammatory bowel disease also remains unclear.

Methods: This study was conducted as a randomized controlled trial at the Hyogo College of Medicine. The study protocols were registered with the University Hospital Medical Information Network Clinical Trials Registry (000013369). In this study, 335 patients with Crohn disease who were scheduled to undergo intestinal resection with an open approach were randomly assigned to either group A or group B. The patients in group A received both preoperative oral antibiotics and intravenous antimicrobial prophylaxis, and intravenous antimicrobial prophylaxis alone was given to the patients in group B. All patients underwent preoperative mechanical bowel preparation with sodium picosulfate hydrate. The primary endpoint of this study was the incidence of surgical site infection (SSI) according to an intention-to-treat analysis.

Results: Although the incidences of overall and organ/space SSI were not significantly different, the incidence of incisional SSI was significantly lower in group A (12/163; 7.4%) than in group B (27/162; 16.6%) (P = 0.01). In the multivariate analysis, the absence of oral antibiotic prophylaxis was an independent risk factor for incisional SSI (odds ratio: 3.3; 95% confidence interval: 1.3-8.3; P = 0.01).

Conclusions: Combined oral and intravenous antimicrobial prophylaxis in patients with Crohn disease contributed to the prevention of SSI.