NCT00613769

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,073 (actual)
• Sponsor: Halmstad County Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Infection Prophylaxis in Colo Rectal Surgery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-09-01
• Primary completion: 2011-12-01
• Completion: 2012-05-01
• First posted: 2008-02-13
• Last updated: 2012-09-28

Locations

6 sites across 1 country: Sweden