Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery - Full Text View

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Cancer Surgery

Drug Information available for: Cefmetazole Cefmetazole sodium

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
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

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

Study ID Numbers:	C000000069
Study First Received:	February 15, 2006
Last Updated:	February 15, 2006
ClinicalTrials.gov Identifier:	NCT00292708 History of Changes
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-Infective Agents
Cefmetazole
Anti-Bacterial Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2009