Randomized clinical trial of single- versus multiple-dose antimicrobial prophylaxis in gastric cancer surgery

Background: The optimum duration of antimicrobial prophylaxis in elective gastric cancer surgery is still open to question. This multicentre randomized clinical trial compared a single-dose with a multiple-dose regimen of antimicrobial prophylaxis for prevention of surgical-site infection. Methods: Between May 2001 and December 2004, 501 patients undergoing elective surgery for gastric cancer in ten centres were allocated randomly to single- or multiple-dose antimicrobial prophylaxis. The primary outcome measure was the incidence of surgical-site infection, analysed by intention to treat. Results: Some 243 patients who received a single dose and 243 who received multiple doses of antibiotics were included in the final analysis. The surgical-site infection rate was 9.5 per cent (23 of 243) and 8.6 per cent (21 of 243) respectively (difference 0.9 (95 per cent confidence interval -4.3 to 5.9) per cent). Antimicrobial prophylaxis had no major adverse effects. Conclusion: The incidence of surgical-site infection in elective gastric cancer surgery was similar with both antibiotic prophylaxis regimens.