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Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery

This study has been completed.
Sponsor:
Information provided by:
National Cancer Center, Japan
ClinicalTrials.gov Identifier:
NCT00292708
First received: February 15, 2006
Last updated: NA
Last verified: February 2006
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
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:

MedlinePlus related topics: Antibiotics Cancer
U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00292708

Locations
Japan
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
Investigators
Principal Investigator: Shin Fujita, MD. PhD. Japan National Cancer Center Hospital
  More Information

Additional Information:
UMIN Clinical Trial Registry: Unique trial number C000000069  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00292708     History of Changes
Other Study ID Numbers: C000000069
Study First Received: February 15, 2006
Last Updated: February 15, 2006
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Anti-Bacterial Agents
Cefmetazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013