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Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery

This study has been completed.
Information provided by:
National Cancer Center, Japan Identifier:
First received: February 15, 2006
Last updated: NA
Last verified: February 2006
History: No changes posted
To determine the optimal prophylactic antibiotics administration method in elective colorectal surgery

Condition Intervention Phase
Colorectal Surgery Drug: Cefmetazole (drug) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Multicenter Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery: Single-Dose Vs. Three Doses of Second-Generation Cephalosporin

Resource links provided by NLM:

Further study details as provided by National Cancer Center, Japan:

Primary Outcome Measures:
  • Incidence of incisional surgical site infection (SSI)

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

Estimated Enrollment: 500
Study Start Date: May 2004
Estimated Study Completion Date: July 2005
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.

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00292708

Ishikawa Prefectural Central Hospital
Kanazawa, Japan
National Cancer Center East Hospital
Kashiwa, Japan
Nagoya Medical Center
Nagoya, Japan
Niigata Cancer Center Hospital
Niigata, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, Japan
National Cancer Center Hospital
Tokyo, Japan
Yamagata Prefectural Central Hospital
Yamagata, Japan
Sponsors and Collaborators
National Cancer Center, Japan
Principal Investigator: Shin Fujita, MD. PhD. Japan National Cancer Center Hospital
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00292708     History of Changes
Other Study ID Numbers: C000000069
Study First Received: February 15, 2006
Last Updated: February 15, 2006

Keywords provided by National Cancer Center, Japan:
Surgical wound infection

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents processed this record on June 22, 2017