Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Surgery Today
Published in: Surgery Today 10/2019

01-10-2019 | Liver Surgery | Original Article

Antimicrobial prophylaxis for 1 day versus 3 days in liver cancer surgery: a randomized controlled non-inferiority trial

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

Published in: Surgery Today | Issue 10/2019

Login to get access

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.
Appendix
Available only for authorised users
Literature
1.
2.
Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site Infection, Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1999;27(2):97–132.CrossRefPubMed
3.
Bratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, Fish DN, Napolitano LM, Sawyer RG, Slain D, Steinberg JP, Weinstein RA, American Society of Health-System Pharmacists; Infectious Disease Society of America; Surgical Infection Society; Society for Healthcare Epidemiology of America. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm. 2013;70(3):195–283.CrossRefPubMed
4.
Teillant A, Gandra S, Barter D, Morgan DJ, Laxminarayan R. Potential burden of antibiotic resistance on surgery and cancer chemotherapy antibiotic prophylaxis in the USA: a literature review and modelling study. Lancet Infect Dis. 2015;15(12):1429–37.CrossRefPubMed
5.
Berríos-Torres SI, Umscheid CA, Bratzler DW, Leas B, Stone EC, Kelz RR, Reinke CE, Morgan S, Solomkin JS, Mazuski JE, Dellinger EP, Itani KMF, Berbari EF, Segreti J, Parvizi J, Blanchard J, Allen G, Kluytmans JAJW, Donlan R, Schecter WP, Healthcare Infection Control Practices Advisory Committee. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. 2017;152(8):784–91.CrossRefPubMed
6.
Alexiou VG, Ierodiakonou V, Peppas G, Falagas ME. Antimicrobial prophylaxis in surgery: an international survey. Surg Infect (Larchmt). 2010;11(4):343–8.CrossRefPubMed
7.
Imamura H, Kurokawa Y, Tsujinaka T, Inoue K, Kimura Y, Iijima S, et al. Intraoperative versus extended antimicrobial prophylaxis after gastric cancer surgery: a phase 3, open-label, randomised controlled, non-inferiority trial. Lancet Infect Dis. 2012;12(5):381–7.CrossRefPubMed
8.
Takayama T, Sekine T, Makuuchi M, Yamasaki S, Kosuge T, Yamamoto J, et al. Adoptive immunotherapy to lower postsurgical recurrence rates of hepatocellular carcinoma: a randomised trial. Lancet. 2000;356(9232):802–7.CrossRefPubMed
9.
Clavien PA, Petrowsky H, DeOliveira ML, Graf R. Strategies for safer liver surgery and partial liver transplantation. N Engl J Med. 2007;356(15):1545–59.CrossRefPubMed
10.
Moreno Elola-Olaso A, Davenport DL, Hundley JC, Daily MF, Gedaly R. Predictors of surgical site infection after liver resection: a multicentre analysis using National Surgical Quality Improvement Program data. HPB (Oxford). 2012;14(2):136–41.CrossRefPubMedPubMedCentral
11.
Nakahira S, Shimizu J, Miyamoto A, Kobayashi S, Umeshita K, Ito T, et al. Proposal for a sub-classification of hepato-biliary-pancreatic operations for surgical site infection surveillance following assessment of results of prospective multicenter data. J Hepatobiliary Pancreat Sci. 2013;20(5):504–11.CrossRefPubMed
12.
Paruch JL, Merkow RP, Bentrem DJ, Ko CY, Posner MC, Cohen ME, et al. Impact of hepatectomy surgical complexity on outcomes and hospital quality rankings. Ann Surg Oncol. 2014;21(6):1773–800.CrossRefPubMed
13.
Wu CC, Yeh DC, Lin MC, Liu TJ, Peng FK. Prospective randomized trial of systemic antibiotics in patients undergoing liver resection. Br J Surg. 1998;85(4):489–93.CrossRefPubMed
14.
Togo S, Tanaka K, Matsuo K, Nagano Y, Ueda M, Morioka D, Endo I, Shimada H. Duration of antimicrobial prophylaxis in patients undergoing hepatectomy: a prospective randomized controlled trial using flomoxef. J Antimicrob Chemother. 2007;59(5):964–70.CrossRefPubMed
15.
Hirokawa F, Hayashi M, Miyamoto Y, Asakuma M, Shimizu T, Komeda K, et al. Evaluation of postoperative antibiotic prophylaxis after liver resection: a randomized controlled trial. Am J Surg. 2013;206(1):8–15.CrossRefPubMed
16.
Takagane A, Mohri Y, Konishi T, Fukushima R, Noie T, Sueyoshi S, et al. Randomized clinical trial of 24 versus 72 h antimicrobial prophylaxis in patients undergoing open total gastrectomy for gastric cancer. Br J Surg. 2017;104(2):e158–e164164.CrossRefPubMed
17.
Gomi H, Solomkin JS, Takada T, Strasberg SM, Pitt HA, Yoshida M, Kusachi S, Mayumi T, Miura F, Kiriyama S, Yokoe M, Kimura Y, Higuchi R, Windsor JA, Dervenis C, Liau KH, Kim MH, Tokyo Guideline Revision Committee. TG13 antimicrobial therapy for acute cholangitis and cholecystitis. J Hepatobiliary Pancreat Sci. 2013;20(1):60–70.CrossRefPubMed
18.
Midorikawa Y, Takayama T, Nara S, Hashimoto T, Omichi K, Ebisawa K, et al. No Need of Immediate Treatment for Hypovascular Tumors Associated with Hepatocellular Carcinoma. World J Surg. 2016;40(10):2460–5.CrossRefPubMed
19.
Levy I, Greig PD, Gallinger S, Langer B, Sherman M. Resection of hepatocellular carcinoma without preoperative tumor biopsy. Ann Surg. 2001;234(2):206–9.CrossRefPubMedPubMedCentral
20.
Liver Cancer Study Group of Japan. The clinical staging of hepatocellular carcinoma. In: Makuuchi M, editor. General rules for the clinical and pathological study of primary liver cancer. 3rd ed. Ltd, Tokyo: Kanehara & Co.; 2010. p. 26–27.
21.
Takayama T, Makuuchi M, Kubota K, Harihara Y, Hui AM, Sano K, et al. Randomized comparison of ultrasonic vs clamp transection of the liver. Arch Surg. 2001;136(8):922–8.CrossRefPubMed
22.
Yamazaki S, Takayama T, Moriguchi M, Mitsuka Y, Okada S, Midorikawa Y, et al. Criteria for drain removal following liver resection. Br J Surg. 2012;99(11):1584–90.CrossRefPubMed
23.
Ban KA, Minei JP, Laronga C, Harbrecht BG, Jensen EH, Fry DE, Itani KM, Dellinger EP, Ko CY, Duane TM. American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016 Update. J Am Coll Surg. 2017;224(1):59–74.CrossRefPubMed
24.
Liu CL, Fan ST, Lo CM, Wong Y, Ng IO, Lam CM, et al. Abdominal drainage after hepatic resection is contraindicated in patients with chronic liver diseases. Ann Surg. 2004;239(2):194–201.CrossRefPubMedPubMedCentral
25.
Pelton JJ, Hoffman JP, Eisenberg BL. Comparison of liver function tests after hepatic lobectomy and hepatic wedge resection. Am Surg. 1998;64(5):408–14.PubMed
26.
Kudo M, Izumi N, Ichida T, Ku Y, Kokudo N, Sakamoto M, et al. Report of the 19th follow-up survey of primary liver cancer in Japan. Hepatol Res. 2016;46(5):372–90.CrossRefPubMed
27.
Ercolani G, Grazi GL, Ravaioli M, Del Gaudio M, Gardini A, Cescon M, et al. Liver resection for hepatocellular carcinoma on cirrhosis: univariate and multivariate analysis of risk factors for intrahepatic recurrence. Ann Surg. 2003;237(4):536–43.PubMedPubMedCentral
28.
Dechartres A, Boutron I, Trinquart L, Charles P, Ravaud P. Single-center trials show larger treatment effects than multicenter trials: evidence from a meta-epidemiologic study. Ann Intern Med. 2011;155(1):39–51.CrossRefPubMed
Metadata
Title
Antimicrobial prophylaxis for 1 day versus 3 days in liver cancer surgery: a randomized controlled non-inferiority trial
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
Publication date
01-10-2019
Publisher
Springer Singapore
Published in
Surgery Today / Issue 10/2019
Print ISSN: 0941-1291
Electronic ISSN: 1436-2813
DOI
https://doi.org/10.1007/s00595-019-01813-w

Other articles of this Issue 10/2019

Surgery Today 10/2019 Go to the issue

Original Article

Super-elderly patient-specific perioperative complications in breast cancer surgery

Original Article

A snapshot of surgical resident training in Japan: results of a national-level needs assessment survey

Review Article

Current status of robot-assisted thoracoscopic surgery for lung cancer

Original Article

Feasibility of robotic radical gastrectomy using a monopolar device for gastric cancer

Original Article

A comparison between 2- and 3-dimensional approaches to solid component measurement as radiological criteria for sublobar resection in lung adenocarcinoma ≤ 2 cm in size

Letter to the Editor

Reply to comment on “Ambiguity about the volume of colloids administration in a clinical study of thoracic esophagectomy precludes conclusion on renal safety of hydroxyethyl starch”