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

Phase 3
Conditions
Colorectal diseases in which elective colorectal resection is necessary
Registration Number
JPRN-C000000069
Lead Sponsor
ational Cancer Center Hospital
Brief Summary

A total of 384 patients were enrolled. Seven patients were excluded because of additional surgery or inability to tolerate mechanical preparation. The incidence of incisional SSI was higher in the single-dose group (27/190, 14%) than in the three-dose group (8/119, 4%) (p = 0.009). Incidences of organ/space SSI and other postoperative infectious diseases did not differ significantly between the two groups. In multivariate analysis, antibiotic dose was the only significant factor related to the incidence of incisional SSI.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
500
Inclusion Criteria

Not provided

Exclusion 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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Incidence of incisional surgical site infection (SSI)
Secondary Outcome Measures
NameTimeMethod
Incidences of organ/space SSI and other infectious diseases. Other postoperative complications and postoperative hospital stay
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