Randomized controlled trial of antibiotic prophylaxis in elective laparoscopic colorectal surgery: Oral and systemic versus systemic antibiotics
Phase 3
- Conditions
- Colorectal tumor with planned elective laparoscopic resection
- Registration Number
- JPRN-UMIN000000776
- Lead Sponsor
- The Japan-Multinational Trial Organization(JMTO)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 580
Inclusion Criteria
Not provided
Exclusion Criteria
1) ECOG Performance Status >=2 2) Age<20 3) Any organ dysfunction 4) Ileus 5) Preoperative infectious disease 6) Antibiotic administration before surgery 7) Steroid administration before surgery 8) Neo-adjuvant radiation and/or chemo therapy 9) Diabetes mellitus 10) Pregnancy/lactational woman 11) Severe allergy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence and classification of surgical site infection (SSI)
- Secondary Outcome Measures
Name Time Method Incidence of colitis, other infectious diseases and other postoperative complications.