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

NCT00613769 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1073

Last updated 2012-09-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Halmstad County Hospital

    lead OTHER

Principal Investigators

  • Claes Hjalmarsson, MD,PhD · Department of Surgery and Oncology, Halland Hospital Halmstad, 301 85 Halmstad, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2011-12-31
Completion
2012-05-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00613769 on ClinicalTrials.gov