Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery - Tabular View

Tracking Information

First Received Date ^ICMJE

February 15, 2006

Last Updated Date

February 15, 2006

Start Date ^ICMJE

May 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Incidence of incisional surgical site infection (SSI)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Incidences of organ/space SSI and other infectious diseases. Other postoperative complications and postoperative hospital stay

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery

Official Title ^ICMJE

Randomized Multicenter Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery: Single-Dose Vs. Three Doses of Second-Generation Cephalosporin

Brief Summary

To determine the optimal prophylactic antibiotics administration method in elective colorectal surgery

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Colorectal Surgery

Intervention ^ICMJE

Drug: Cefmetazole (drug)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

500

Completion Date

July 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00292708

Responsible Party

Study ID Numbers ^ICMJE

C000000069

Study Sponsor ^ICMJE

National Cancer Center, Japan

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Shin Fujita, MD. PhD.

Japan National Cancer Center Hospital

Information Provided By

National Cancer Center, Japan

Verification Date

February 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP