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


Phase 3
20 Years
80 Years
Not Enrolling
Both
Colorectal Surgery

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of incisional surgical site infection (SSI)

Principal Investigator

Shin Fujita, MD. PhD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Japan National Cancer Center Hospital

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

C000000069

NCT ID:

NCT00292708

Start Date:

May 2004

Completion Date:

July 2005

Related Keywords:

  • Colorectal Surgery
  • Antibiotics
  • Prophylaxis
  • Surgical wound infection

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