Orally Administered Trimethoprim-sulfamethoxazole and Metronidazole as Prophylaxis of Infection Following Elective Colorectal Surgery
|ClinicalTrials.gov Identifier: NCT00613769|
Recruitment Status : Completed
First Posted : February 13, 2008
Last Update Posted : September 28, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Infection Prophylaxis in Colo Rectal Surgery||Drug: trimethoprim-sulfamethoxazole + metronidazole Drug: cefuroxime and metronidazole||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1073 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||September 2007|
|Primary Completion Date :||December 2011|
|Study Completion Date :||May 2012|
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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|