NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000069

Registered date:19/08/2005

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedColorectal diseases in which elective colorectal resection is necessary
Date of first enrollment2004/05/01
Target sample size500
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeIncidence of incisional surgical site infection (SSI)
Secondary OutcomeIncidences of organ/space SSI and other infectious diseases. Other postoperative complications and postoperative hospital stay

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteria1) 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

Contact

public contact
Name Shin Fujita
Address 1-1, Tsukiji 5-chome, Chuo-ku, Tokyo Japan
Telephone 03-3542-2511
E-mail sfujita@ncc.go.jp
Affiliation National Cancer Center Hospital Colorectal Surgery Division
scientific contact
Name Shin Fujita
Address 1-1, Tsukiji 5-chome, Chuo-ku, Tokyo Japan
Telephone 03-3542-2511
E-mail
Affiliation National Cancer Center Hospital Colorectal Surgery Division