NCT00292708CompletedPhase 3
Randomized Multicenter Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery: Single-Dose Vs. Three Doses of Second-Generation Cephalosporin
National Cancer Center, Japan7 sites in 1 country500 target enrollmentStarted: May 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 500
- Locations
- 7
- Primary Endpoint
- Incidence of incisional surgical site infection (SSI)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Colorectal diseases (cancer, large polyp, carcinoid, lymphoma,sarcoma and so on)
- •Elective colorectal resection
Exclusion Criteria
- •Emergent operation
- •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
Outcomes
Primary Outcomes
Incidence of incisional surgical site infection (SSI)
Secondary Outcomes
- Incidences of organ/space SSI and other infectious diseases. Other postoperative complications and postoperative hospital stay
Investigators
Study Sites (7)
Loading locations...
Similar Trials
Completed
Phase 3
Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic AntibioticsColorectal NeoplasmsNCT00508690Japan Multinational Trial Organization584
Completed
Phase 2
Safety and Efficacy of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal SurgeryColorectal SurgeryNCT01220661National Cancer Center, Korea312
Completed
Phase 2
Continuous Antibiotic Prophylaxis in Colorectal SurgerySurgical Site InfectionNCT02445859University of Leeds90
Unknown
Phase 2
Administration of Antibiotic Prophylaxis for Transperineal Prostate Biopsy in Cipto Mangunkusumo HospitalProstate BiopsyPerioperative ComplicationBacteriuriaUrinary Tract InfectionsProstate CancerSepsisNCT04985110Indonesia University78
Completed
Not Applicable
Antibiotic PRophylAxis Based on infeCTIve Risk in Cardiac Implantable Electronic DeviceDevice Related InfectionNCT04736979University Hospital of Ferrara1,044