Randomized clinical trial about the period of antimicrobial prophylaxis administration in rectal cancer surgery

UMIN ID: UMIN000000993

Registered date:25/01/2008

Basic Information

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

Intervention(s)

Cefmetazole 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
Cefmetazole 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: The exclusion criteria were a bowel obstruction or stenosis, reconstruction of stoma before rectal resection, laparoscopic surgery, combined resection with other organ, known allergy to a beta-lactam, treatment with any antibiotic within the past 2 weeks, pregnancy, and evidence of an infection at the time of surgery, ASA score more than 3, and recived preoperative chemoterapy and/or radiotherapy. Patients are also excluded if they had liver or cardiac, renal dysfunction, and if their physician decided unfit for this study.

Related Information

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