NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000002852

Registered date:09/12/2009

Randomized clinical trial about the period of antimicrobial prophylaxis administration in hepatocellular carcinoma surgery

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedPatients undergoing elective hepatocellular carcinoma surgery
Date of first enrollment2008/05/01
Target sample size460
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Flomoxef Sodium is administered afetr the induction of anesthesia, and the patients recieved an additional dose if the operation was prolonged beyond 3 hour, and cefmetazole was administered agin twice daily for 3 concecutive days after the operation Flomoxef Sodium is administered after the induction of anesthesia, and the patients received an additional dose if the operation was prolonged beyond 3 hour, and cefmetazole was administered at 6 hour and 18hour at end of the oparation.

Outcome(s)

Primary OutcomeThe primary outcome is to show that a 24 hours antibiotic administarion of the end of the operation was not inferior to the 3 days antibiotic administration of the postoperative period .
Secondary OutcomeThe secondary outcome is to investigate the incidence of remote infection in each group.

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteriaHepatocellular carcinoma patients undergoing liver resection Liver damage A ECOG Performance Status Scale:0-2 Written informed consent.
Exclude criteriaLaparoscopic surgery Thoracotomy Digestive organ or vessel reconstruction Other organ resection. Those with cardiac dysfunction, renal dysfunction, Those who received insulin or steroid therapy. Those who were allergic to cefem or penicillin, pregnant, received antibiotic treatment in the past 2 weeks, had an infection at the time of surgery. A woman who is pregnant, lactating, or may become pregnant. ASA score >3. Exclude the patients who are recognized as inadequate patients by doctors with responsibility in this trial.

Related Information

Contact

public contact
Name Masato Kusunoki
Address 2-174, Edobashi, Tsu, Mie, 514-8507, Japan Japan
Telephone 059-231-5305
E-mail
Affiliation Japan Society for Surgical Infection Chairman of randomized clinical trial committee
scientific contact
Name Yoshinobu Sumiyama
Address 2-17-6, Ohashi, Meguro-Ku, Tokyo, 153-8515, Japan Japan
Telephone 03-3481-7316
E-mail
Affiliation Japan Society for Surgical Infection The Chief director