Trial | NCT00613769  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    1073
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.
Study Started
Sep 30
2007
Primary Completion
Dec 31
2011
Study Completion
May 31
2012
Last Update
Sep 28
2012
Estimate

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.

ordinary per operative prophylaxis Active Comparator

cefuroxime(1500mg) i.v.+ metronidazole (1500mg)i.v.given at the time point of induction of anesthesia

Per oral alternative Experimental

Trimethoprim-sulfamethoxazole(160mg/800mg)p.o.+metronidazole (1200mg)p.o.given 06.00 am on the day of operation

Criteria 

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
No Results Posted