O04 – A prospective randomized study to assess the optimal duration of antimicrobial prophylaxis in total gastrectomy
Author(s):
Background: Western guidelines stated that the duration of antimicrobial prophylaxis (AMP) should be less than 24 hours postoperatively for most surgical procedures. However, some patients in gastrectomy especially in Japan still receive further extended AMP until 3-4 postoperative days. In contrast to western countries, extended D2 lymphadenectomy has been a standard surgical treatment for gastric cancer in Japan (and in Eastern Asia) and high prevalence of drain use may be a potential risk for surgical site infections (SSI). There is not much information regarding the optimal duration of AMP in total gastrectomy with D2 lymphadenectomy.
Hypothesis: A muti-center prospective, open-label, randomized controlled trial to assess the optimal duration of AMP in total gastrectomy was conducted.
Methods: Patients with gastric cancer who underwent total gastrectomy (R0 resection) were randomly assigned (1:1) to group A: 24-hour AMP (ampicillin/sulbactam 1.5 g before the surgical incision and every 3 hour during surgery, 6 hours after wound closure and once on the next day) or group B: 72-hour AMP (ampicillin/sulbactam 1.5 g twice daily extended until postoperative day 3). The primary endpoint was the incidence of SSI and secondary endpoint was the incidence of remote infections. We assessed non-inferiority of 24-hour prophylaxis with a margin of 9%. This study was registered in UMIN-CTR, UMIN000001062.
Results: Between February 28, 2008, and March 31, 2012, 476 patients from 67 hospitals were included and 462 patients were analyzed (group A: n= 227, group B: n=235).
The two groups did not differ significantly in relation to age, sex, body mass index, cancer stages and operative procedures. Incidences of infections are presented in the table. The results showed statistically significant non-inferiority (p<0.0001) of group A over group B in terms of the incidence rate of SSI.
Conclusions: antimicrobial prophylaxis should be limited to 24 hours postoperatively in total gastrectomy.