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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00613769

Enrollment

1073

Registered

2008-02-13

Start date

2007-09-30

Completion date

2012-05-31

Last updated

2012-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection Prophylaxis in Colo Rectal Surgery

Keywords

Surgical site infections

Brief 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.

Interventions

DRUGtrimethoprim-sulfamethoxazole + metronidazole

trimethoprim-sulfamethoxazole (160mg/800mg)p.o.+ metronidazole (1200mg)p.o.

DRUGcefuroxime and metronidazole

cefuromime 1500mg i.v. + metronidazole 1500mg i.v.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Cutaneous-,subcutaneous and intraabdominal infections	4 weeks

Secondary

Measure	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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026