Orally Administered Trimethoprim-sulfamethoxazole and Metronidazole as Prophylaxis of Infection Following Elective Colorectal Surgery

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Infection Prophylaxis in Colo Rectal Surgery

Intervention / Treatment
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* Drug: trimethoprim-sulfamethoxazole + metronidazole
* Drug: cefuroxime and metronidazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >= 18 years Planned clean/clean-contaminated colorectal resection will be performed Understand spoken and written swedish language Exclusion Criteria: Hypersensibility to the test or control drug Severe liver failure Blood dyscrasia Ileus or gastric retention Current visceral perforation Current treatment with antibiotics Current treatment with steroids Cytotoxic or radiation therapy within 4 weeks of the planned operation Active IBD (inflammatory bowel disease) Incapability to swallow tablets Other study interfering with this study Current pregnancy Bad regulated diabetes Current enterocutaneous or colocutaneous fistula

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ordinary per operative prophylaxis<br>cefuroxime(1500mg) i.v.+ metronidazole (1500mg)i.v.given at the time point of induction of anesthesia | Drug: cefuroxime and metronidazole<br>* cefuromime 1500mg i.v. + metronidazole 1500mg i.v.<br>|
| Experimental: Per oral alternative<br>Trimethoprim-sulfamethoxazole(160mg/800mg)p.o.+metronidazole (1200mg)p.o.given 06.00 am on the day of operation | Drug: trimethoprim-sulfamethoxazole + metronidazole<br>* trimethoprim-sulfamethoxazole (160mg/800mg)p.o.+ metronidazole (1200mg)p.o.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cutaneous-,subcutaneous and intraabdominal infections |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non infectious wound complications |  | 4 weeks | 
| Complications to the anastomosis |  | 4 weeks | 
| Adverse reaction of given drug |  | 4 weeks | 
| Other post operative infections |  | During hospital stay | 
| Septicaemia |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical site infections