Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery
- Conditions
- Colorectal Surgery
- Registration Number
- NCT00292708
- Lead Sponsor
- National Cancer Center, Japan
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
- Colorectal diseases (cancer, large polyp, carcinoid, lymphoma,sarcoma and so on)
- Elective colorectal resection
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of incisional surgical site infection (SSI)
- Secondary Outcome Measures
Name Time Method Incidences of organ/space SSI and other infectious diseases. Other postoperative complications and postoperative hospital stay
Trial Locations
- Locations (7)
Nagoya Medical Center
🇯🇵Nagoya, Japan
Niigata Cancer Center Hospital
🇯🇵Niigata, Japan
National Cancer Center Hospital
🇯🇵Tokyo, Japan
Ishikawa Prefectural Central Hospital
🇯🇵Kanazawa, Japan
National Cancer Center East Hospital
🇯🇵Kashiwa, Japan
Yamagata Prefectural Central Hospital
🇯🇵Yamagata, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
🇯🇵Osaka, Japan