Comparison of two preoperative antibiotic profilaxis to prevent surgical complications, infections in colonic surgery
- Conditions
- In colorectal surgery wildely used bowel prep and systemic antibiotic prophylaxis. New data suggest that infective complications can be lowered if beside this regimen oral antibiotic profilaxis is applied.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2015-005614-30-HU
- Lead Sponsor
- zsoki Utcai Kórház
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 450
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method