Orally Administered Trimethoprim-sulfamethoxazole and Metronidazole as Prophylaxis of Infection Following Elective Colorectal Surgery
The current standard Swedish infection prophylaxis in colorectal surgery is intravenously administered cefuroxime and metronidazole. this combination is well studied. The disadvantages of the regimen is "collateral damage" resulting from treatment with a cephalosporine and that the combination also serves as the first line of treatment for abdominal surgical infections.
Serval Swedish surgical departments have for some years used a combination of orally administered trimethoprim-sulfamethoxazole and metronidazole.
The combination is economical and believed to be effective but hitherto the outcome have not been properly researched.
The aim of this study is to compare the efficacy of these two regimens in the prevention of infection after elective colorectal surgery.
|Infection Prophylaxis in Colo Rectal Surgery||Drug: trimethoprim-sulfamethoxazole + metronidazole Drug: cefuroxime and metronidazole||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Prospective, Randomized, Blind, Multicenter Trial Comparing Orally Administered Trimethoprim-sulfamethoxazole With Intravenously Administered Cefuroxime and Metronidazole as Prophylaxis of Infection Following Elective Colorectal Surgery|
- Cutaneous-,subcutaneous and intraabdominal infections [ Time Frame: 4 weeks ]
- Non infectious wound complications [ Time Frame: 4 weeks ]
- Complications to the anastomosis [ Time Frame: 4 weeks ]
- Adverse reaction of given drug [ Time Frame: 4 weeks ]
- Other post operative infections [ Time Frame: During hospital stay ]
- Septicaemia [ Time Frame: 4 weeks ]
|Study Start Date:||September 2007|
|Study Completion Date:||May 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Active Comparator: ordinary per operative prophylaxis
cefuroxime(1500mg) i.v.+ metronidazole (1500mg)i.v.given at the time point of induction of anesthesia
Drug: cefuroxime and metronidazole
cefuromime 1500mg i.v. + metronidazole 1500mg i.v.
Experimental: Per oral alternative
Trimethoprim-sulfamethoxazole(160mg/800mg)p.o.+metronidazole (1200mg)p.o.given 06.00 am on the day of operation
Drug: trimethoprim-sulfamethoxazole + metronidazole
trimethoprim-sulfamethoxazole (160mg/800mg)p.o.+ metronidazole (1200mg)p.o.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00613769
|Department of Surgery, University hospital Sahlgrenska/Östra|
|Gothenburg, Sweden, 416 85|
|Department of Surgery and oncology, Halland Hospital in Halmstad|
|Halmstad, Sweden, 301 85|
|Department of surgery, Community Hospital i Karlskrona|
|Karlskrona, Sweden, 371 85|
|Norrköping, Sweden, 601 82|
|Department of surgery|
|Skövde, Sweden, 541 85|
|Department of Surgery, NU-hospitals|
|Uddevalla, Sweden, 451 80|
|Principal Investigator:||Claes Hjalmarsson, MD,PhD||Department of Surgery and Oncology, Halland Hospital Halmstad, 301 85 Halmstad, Sweden|