Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery

NCT00292708 ↗

Phase 3 Completed 500 enrolled National Cancer Center, Japan

RandomizedParallel-groupOpen-labelTreatment

Summary

To determine the optimal prophylactic antibiotics administration method in elective colorectal surgery

Timeline

Start: 2004-05
Primary completion: —
Completion: 2005-07

Outcome

Met primary endpoint

paper The incidence of incisional SSI was higher in the single-dose group (27/190 or 14.2%) than in the 3-dose group (8/187 or 4.3%) (P = .009). PMID 17638804 ↗

paper Three-dose cefmetazole administration is significantly more effective for prevention of incisional SSI than single-dose antibiotic administration. PMID 17638804 ↗

Publications

Fujita S, Saito N, Yamada T, Takii Y, Kondo K, Ohue M, Ikeda E, Moriya Y. Randomized, multicenter trial of antibiotic prophylaxis in elective colorectal surgery: single dose vs 3 doses of a second-generation cephalosporin without metronidazole and oral antibiotics. Arch Surg. 2007 Jul;142(7):657-61. doi: 10.1001/archsurg.142.7.657.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cefmetazole	Small molecule	—	—

Indications

No indication recorded.