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| Sponsored by: |
National Cancer Center, Japan |
| Information provided by: | National Cancer Center, Japan |
| ClinicalTrials.gov Identifier: | NCT00292708 |
Purpose
To determine the optimal prophylactic antibiotics administration method in elective colorectal surgery
| Condition | Intervention | Phase |
|
Colorectal Surgery |
Drug: Cefmetazole (drug) |
Phase III |
| MedlinePlus related topics: | Antibiotics Cancer |
| ChemIDplus related topics: | Cefmetazole Cefixime Cefmetazole sodium |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Randomized Multicenter Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery: Single-Dose Vs. Three Doses of Second-Generation Cephalosporin |
| Estimated Enrollment: | 500 |
| Study Start Date: | May 2004 |
| Estimated Study Completion Date: | July 2005 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Japan | |||||
| National Cancer Center Hospital | |||||
| Tokyo, Japan | |||||
| National Cancer Center East Hospital | |||||
| Kashiwa, Japan | |||||
| Ishikawa Prefectural Central Hospital | |||||
| Kanazawa, Japan | |||||
| Yamagata Prefectural Central Hospital | |||||
| Yamagata, Japan | |||||
| Nagoya Medical Center | |||||
| Nagoya, Japan | |||||
| Osaka Medical Center for Cancer and Cardiovascular Diseases | |||||
| Osaka, Japan | |||||
| Niigata Cancer Center Hospital | |||||
| Niigata, Japan | |||||
| National Cancer Center, Japan |
| Principal Investigator: | Shin Fujita, MD. PhD. | Japan National Cancer Center Hospital |
More Information
UMIN Clinical Trial Registry: Unique trial number C000000069 
  |
| Study ID Numbers: | C000000069 |
| First Received: | February 15, 2006 |
| Last Updated: | February 15, 2006 |
| ClinicalTrials.gov Identifier: | NCT00292708 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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