Randomized multicentre trial of antibiotic prophylaxis in elective colorectal surgery: Single dose of cefmetazole vs. three doses of cefmetazole

UMIN ID: C000000069

Registered date:19/08/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Colorectal diseases in which elective colorectal resection is necessary
• Date of first enrollment: 2004/05/01
• Target sample size: 500
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Single intravenous dose of 1 g cefmetazole just before skin incision,
Three-dose group given an intravenous dose of 1 g cefmetazole just before skin incision, and two postoperative 1-g doses at 8 and 16 h after the first administration.

Outcome(s)

• Primary Outcome: Incidence of incisional surgical site infection (SSI)
• Secondary Outcome: Incidences of organ/space SSI and other infectious diseases. Other postoperative complications and postoperative hospital stay

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1) Age < 20, 80 < Age 2) Emergent operation 3) Ileus 4) No resection 5) Preoperative infectious diseases 6) Penicillin or cephalosporin allergy 7) Antibiotics administration before surgery 8) Inflammatory bowel diseases 9) Angina or myocardial infarction 10) Renal dysfunction 11) Diabetes mellitus 12) Steroid administration before surgery

Related Information

• Primary Sponsor: National Cancer Center Hospital
• Source(s) of Monetary Support: Cancer reseach promotion fund