Antimicrobial Prophylaxis for 1 Day Versus 3 Days in Liver Cancer Surgery: a Randomized Controlled Non-inferiority Trial

Overview

Journal Surg Today

Specialty General Surgery

Date 2019 Apr 29

PMID 31030266

Citations 5

Authors

Tadatoshi Takayama

Osamu Aramaki

Taro Shibata

Masaaki Oka

Toshiyuki Itamoto

Mitsuo Shimada

Shuji Isaji

Takashi Kanematsu

Shoji Kubo

Masato Kusunoki

Hidetaka Mochizuki

Yoshinobu Sumiyama

Affiliations

Soon will be listed here.

Abstract

Purposes: This study compared the effectiveness of 1-day vs 3-days antibiotic regimen to prevent surgical site infection (SSI) in open liver resection.

Method: We performed a randomized controlled non-inferiority trial in 480 patients at 39 hospitals across Japan (registered as UMIN000002852). Patients with hepatocellular carcinoma scheduled to undergo resection were randomly assigned to receive either a 1-day regimen for antimicrobial prophylaxis, or a 3-day regimen. The primary endpoint was the incidence of SSI.

Results: Among 480 randomized patients, 232 assigned to the 1-day regimen and 235 to the 3-day regimen were included in the full analysis set. Baseline characteristics of the two groups were well balanced. SSI was diagnosed in 22 patients (9.5%) in the 1-day group vs 23 patients (9.8%) in the 3-day group (difference, - 0.30; 90% CI - 4.80 to 4.19% [95% CI - 5.66% to 5.05%]; one-sided P = 0.001 for non-inferiority), meeting the non-inferiority hypothesis. In both groups, remote site infection (16 [6.9%] vs 22 [9.4%], P ˂ 0.001 for non-inferiority) and drain-related infection (5 [2.2%] vs 4 [1.7%], P ˂ 0.001 for non-inferiority) were comparable.

Conclusion: To prevent SSI in liver cancer surgery, a 1-day regimen of flomoxef sodium is recommended for antimicrobial prophylaxis because of confirming the non-inferiority to longer usage.

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