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

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

U.S. FDA Resources

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

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

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

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