EUCTR2015-005614-30-HUActive, not recruitingPhase 1
SOAP Antibiotic prophylaxis trial Systemic versus combined systemic and Oral Antibiotic Prophylaxis in elective colorectal surgery - SOAP trial
zsoki Utcai Kórház0 sites450 target enrollmentStarted: May 12, 2016Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 450
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •1. Voluntary participation agreement to the trial.
- •2. Indication for colorectal resection (benign/malignant disease, diverticulosis, colitis, IBD)
- •3. No contraindication for colorectal resection, and the survival expectation is more than 30 days
- •4. Age over 18
- •5. Preserved consciousness
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 250
Exclusion Criteria
- •1. Refusing the participation in the trial
- •2. Previous intrabdominal sepsis/abscess 6 month before surgery
- •3. Urgent surgery
- •4. No resection and anastomosis at the procedure
- •5. Antibiotic treatment 14 days prior to surgery
- •6. Chronic steroid medication or immun compromised state
- •7. Allergy on any medicines of the trial
- •8. Gravidity, lactation
- •9. Protocol violence
- •10. Bowel preparation was unsuccesfull
Investigators
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