Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery

National Cancer Center, Japan

Status and phase: Completed; Phase 3

Conditions: Colorectal Surgery

Treatments: Drug: Cefmetazole (drug)

Study type: Interventional

Funder types: Other

Identifiers

NCT00292708

C000000069

Details and patient eligibility

About

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

Full description

Use of prophylactic antibiotics in elective colorectal surgery is essential. Although single-dose prophylactic antibiotics are recommended, the efficacy of single-dose cephalosporin without metronidazole and oral antibiotics is not fully proven. We conducted a multicenter randomized trial of single-dose vs. three doses of the second-generation cephalosporin, cefmetazole.

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Colorectal diseases (cancer, large polyp, carcinoid, lymphoma,sarcoma and so on)
• Elective colorectal resection

Exclusion criteria

• Emergent operation
• Ileus
• No resection
• Preoperative infectious diseases
• Penicillin or cephalosporin allergy
• Antibiotics administration before surgery
• Inflammatory bowel diseases
• Angina or myocardial infarction
• Renal dysfunction
• Diabetes mellitus
• Steroid administration before surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)