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

UMIN ID: UMIN000002852

Registered date:09/12/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients undergoing elective hepatocellular carcinoma surgery
• Date of first enrollment: 2008/05/01
• Target sample size: 460
• Countries of recruitment: Japan
• Study type: Interventional

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 Outcome: The 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 Outcome: The secondary outcome is to investigate the incidence of remote infection in each group.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: Laparoscopic 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

• Primary Sponsor: Randomized clinical trial committee, Japan Society for Surgical Infection
• Source(s) of Monetary Support: Japan Society for Surgical Infection