Randomized Controlled Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics
Overview
- Phase
- Phase 3
- Intervention
- cefmetazole
- Conditions
- Colorectal Neoplasms
- Sponsor
- Japan Multinational Trial Organization
- Enrollment
- 584
- Locations
- 5
- Primary Endpoint
- Incidence and classification of surgical site infection (SSI)
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study is to determine optimal prophylactic antibiotics administration method in elective laparoscopic colorectal surgery.
Detailed Description
The use of antibiotic prophylaxis in patients who undergo elective colorectal surgery is now accepted universally. But the rout of administration should be systematic, oral, or both is controversial. Furthermore, although many trails have been performed, no trial limited to laparoscopic surgery is performed. We compare 2 approaches - oral and systemic versus systemic antibiotic prophylaxis - in limited to elective laparoscopic colorectal surgery.
Investigators
Hiroaki Hata
member
Japan Multinational Trial Organization
Eligibility Criteria
Inclusion Criteria
- •Colorectal tumor(cancer, adenoma and suspected cases) with planned elective laparoscopic colorectal resection
Exclusion Criteria
- •ECOG Performance Status \>=2
- •Any organ dysfunction
- •Preoperative infectious disease
- •Antibiotic administration before surgery
- •Steroid administration before surgery
- •Neo-adjuvant radiation and/or chemo therapy
- •Severe diabetes mellitus
- •Pregnancy/lactational woman
- •Severe allergy
Arms & Interventions
IV
Intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery
Intervention: cefmetazole
Oral/IV
2 doses of oral kanamycin(1g)/ metronidazole(750mg) administration on the day before surgery with intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery
Intervention: kanamycin/metronidazole
Outcomes
Primary Outcomes
Incidence and classification of surgical site infection (SSI)
Time Frame: Within the first 30 days after surgery
Secondary Outcomes
- Incidence of colitis, other infectious diseases and other postoperative complications.(Within the first 30 days after surgery)