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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2011

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.

Arms, Groups and Cohorts

  • Active Comparator: ordinary per operative prophylaxis
    • cefuroxime(1500mg) i.v.+ metronidazole (1500mg)i.v.given at the time point of induction of anesthesia
  • Experimental: Per oral alternative
    • Trimethoprim-sulfamethoxazole(160mg/800mg)p.o.+metronidazole (1200mg)p.o.given 06.00 am on the day of operation

Clinical Trial Outcome Measures

Primary Measures

  • Cutaneous-,subcutaneous and intraabdominal infections
    • Time Frame: 4 weeks

Secondary Measures

  • Non infectious wound complications
    • Time Frame: 4 weeks
  • Complications to the anastomosis
    • Time Frame: 4 weeks
  • Adverse reaction of given drug
    • Time Frame: 4 weeks
  • Other post operative infections
    • Time Frame: During hospital stay
  • Septicaemia
    • Time Frame: 4 weeks

Participating in This Clinical Trial

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: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Halmstad County Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Claes Hjalmarsson, MDPhD – Halmstad County Hospital
  • Overall Official(s)
    • Claes Hjalmarsson, MD,PhD, Principal Investigator, Department of Surgery and Oncology, Halland Hospital Halmstad, 301 85 Halmstad, Sweden

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