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Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery

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ClinicalTrials.gov Identifier: NCT00292708
Recruitment Status : Completed
First Posted : February 16, 2006
Last Update Posted : February 16, 2006
Sponsor:
Information provided by:

Study Description
Brief Summary:
To determine the optimal prophylactic antibiotics administration method in elective colorectal surgery

Condition or disease Intervention/treatment Phase
Colorectal Surgery Drug: Cefmetazole (drug) Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2004
Estimated Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00292708     History of Changes
Other Study ID Numbers: C000000069
First Posted: February 16, 2006    Key Record Dates
Last Update Posted: February 16, 2006
Last Verified: February 2006

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

Additional relevant MeSH terms:
Anti-Bacterial Agents
Cefmetazole
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents