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Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00292708
Enrollment
500
Registered
2006-02-16
Start date
2004-05-31
Completion date
2005-07-31
Last updated
2006-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Surgery

Keywords

Antibiotics, Prophylaxis, Surgical wound infection

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.

Interventions

Sponsors

National Cancer Center, Japan
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Incidence of incisional surgical site infection (SSI)

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026