Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery

National Cancer Center, Japan500 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

500

Conditions

Colorectal Surgery

Interventions

Cefmetazole (drug)DRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (7)

Ishikawa Prefectural Central Hospital

Kanazawa, Japan

National Cancer Center East Hospital

Kashiwa, Japan

Nagoya Medical Center

Nagoya, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Outcomes

Primary Outcomes

Incidence of incisional surgical site infection (SSI)

Secondary Outcomes

Incidences of organ/space SSI and other infectious diseases. Other postoperative complications and postoperative hospital stay

Data from ClinicalTrials.gov

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