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

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”

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.

Intervention(s) in this Clinical Trial

• Drug: trimethoprim-sulfamethoxazole + metronidazole
  • trimethoprim-sulfamethoxazole (160mg/800mg)p.o.+ metronidazole (1200mg)p.o.
• Drug: cefuroxime and metronidazole
  • cefuromime 1500mg i.v. + metronidazole 1500mg i.v.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • cefuroxime(1500mg) i.v.+ metronidazole (1500mg)i.v.
• Experimental: 2
  • Trimethoprim-sulfamethoxazole(160mg/800mg)p.o.+metronidazole (1200mg)p.o.

Primary Measures

• Cutaneous-,subcutaneous and intraabdominal infections
  • Time Frame: 4 weeks
    Safety Issue?: No

Secondary Measures

• Non infectious wound complications
  • Time Frame: 4 weeks
    Safety Issue?: No
• Complications to the anastomosis
  • Time Frame: 4 weeks
    Safety Issue?: No
• Adverse reaction of given drug
  • Time Frame: 4 weeks
    Safety Issue?: Yes
• Other post operative infections
  • Time Frame: During hospital stay
    Safety Issue?: No
• Septicaemia
  • Time Frame: 4 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Halmstad County Hospital Other

Overall Clinical Trial Officials and Contacts

Claes Hjalmarsson, MD,PhD Principal Investigator Department of Surgery and Onkology, Community Hospital in Halmstad, 301 85 Halmstad, Sweden  

Overall Contact: Claes Hjalmarsson, MD,PhD 0046-35-131000 claes.hjalmarsson@regionhalland.se

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00613769

Study ID Number: TSM

ClinicalTrials.gov Identifier: NCT00613769

Health Authority: Sweden: Medical Products Agency