Parenteral Antibiotics Compared to Combination of Oral and Parenteral Antibiotics in Colorectal Surgery Prophylaxis
Summary
Routine antibiotics for the intravenous and oral prophylaxis of colorectal surgery will be used. Experimental group: Patients undergoing elective colorectal surgery that involves, colonic resection. The antibiotic prophylaxis in this group will be composed of: An oral antibiotic pattern of ciprofloxacin (750mg / 12h, 2 doses) and metronidazole (250mg / 8h, 3 doses) the day before surgery. \+ Control group: Patients undergoing elective colorectal surgery that involves, colonic resection. The antibiotic prophylaxis in this group will be composed of: An intravenous antibiotic pattern of cefuroxime 1g and metronidazole 1,5gr during anesthetic induction. In both groups a second intravenous dose of cefuroxime (750mg) will be administered if the intraoperative time elongates more than three hours or there is an intraoperative bleeding over 1000cc. There won´t be a placebo treatment. Subject compliance will be evaluated according to the usual practice in surgical care field
Timeline
- Start
- 2015-05
- Primary completion
- 2017-04
- Completion
- 2018-11-10
Outcome
Met primary endpoint
paper The incidence of surgical-site infections in the control group (30 [11%] of 269) was significantly higher than in the experimental group (13 [5%] of 267; χ2 test p=0·013). PMID 32325012 ↗
paper Oral antibiotics were associated with a significant reduction in the risk of surgical-site infections compared with no oral antibiotics (odds ratio 0·41, 95% CI 0·20-0·80; p=0·008). PMID 32325012 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ciprofloxacin | Small molecule | 750 mg | Oral |
| Subject | Metronidazole | Small molecule | 250 mg | Oral |
| Subject | Metronidazole | Small molecule | 1 g | Oral |
| Background | Cefuroxime | Small molecule | 1.5 g | Intravenous |
Indications
No indication recorded.