Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery

Colorectal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00292708
• Other study ID #: C000000069
• Status: Completed
• Phase: Phase 3
• First received: February 15, 2006
• Last updated: February 15, 2006
• Start date: May 2004
• Est. completion date: July 2005

Study information

• Verified date: February 2006
• Source: National Cancer Center, Japan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Surgery

Intervention

Drug:
• Cefmetazole (drug)

Locations

Country	Name	City	State
Japan	Ishikawa Prefectural Central Hospital	Kanazawa
Japan	National Cancer Center East Hospital	Kashiwa
Japan	Nagoya Medical Center	Nagoya
Japan	Niigata Cancer Center Hospital	Niigata
Japan	Osaka Medical Center for Cancer and Cardiovascular Diseases	Osaka
Japan	National Cancer Center Hospital	Tokyo
Japan	Yamagata Prefectural Central Hospital	Yamagata

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of incisional surgical site infection (SSI)
Secondary	Incidences of organ/space SSI and other infectious diseases. Other postoperative complications and postoperative hospital stay

External Links

•   UMIN Clinical Trial Registry: Unique trial number C000000069