- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00292708
Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery
February 15, 2006 updated by: National Cancer Center, Japan
Randomized Multicenter Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery: Single-Dose Vs. Three Doses of Second-Generation Cephalosporin
To determine the optimal prophylactic antibiotics administration method in elective colorectal surgery
Study Overview
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 Type
Interventional
Enrollment
500
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kanazawa, Japan
- Ishikawa Prefectural Central Hospital
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Kashiwa, Japan
- National Cancer Center East Hospital
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Nagoya, Japan
- Nagoya Medical Center
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Niigata, Japan
- Niigata Cancer Center Hospital
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Osaka, Japan
- Osaka Medical Center for Cancer and Cardiovascular Diseases
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Tokyo, Japan
- National Cancer Center Hospital
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Yamagata, Japan
- Yamagata Prefectural Central Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Incidence of incisional surgical site infection (SSI)
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Secondary Outcome Measures
Outcome Measure |
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Incidences of organ/space SSI and other infectious diseases. Other postoperative complications and postoperative hospital stay
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shin Fujita, MD. PhD., Japan National Cancer Center Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2004
Study Completion
July 1, 2005
Study Registration Dates
First Submitted
February 15, 2006
First Submitted That Met QC Criteria
February 15, 2006
First Posted (Estimate)
February 16, 2006
Study Record Updates
Last Update Posted (Estimate)
February 16, 2006
Last Update Submitted That Met QC Criteria
February 15, 2006
Last Verified
February 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C000000069
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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