Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery

Overview

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

Full Title of Study: “Randomized Multicenter Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery: Single-Dose Vs. Three Doses of Second-Generation Cephalosporin”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

Detailed 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.

Interventions

  • Drug: Cefmetazole (drug)

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of incisional surgical site infection (SSI)

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Cancer Center, Japan
  • Overall Official(s)
    • Shin Fujita, MD. PhD., Principal Investigator, Japan National Cancer Center Hospital

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