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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Claes Hjalmarsson, Halmstad County Hospital
ClinicalTrials.gov Identifier:
NCT00613769
First received: January 31, 2008
Last updated: September 27, 2012
Last verified: September 2012
History of Changes

January 31, 2008
September 27, 2012
September 2007
December 2011   (final data collection date for primary outcome measure)
Cutaneous-,subcutaneous and intraabdominal infections [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00613769 on ClinicalTrials.gov Archive Site
  • Non infectious wound complications [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Complications to the anastomosis [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Adverse reaction of given drug [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Other post operative infections [ Time Frame: During hospital stay ] [ Designated as safety issue: No ]
  • Septicaemia [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Non infectious wound complications [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Complications to the anastomosis [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Adverse reaction of given drug [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Infection Prophylaxis in Colo Rectal Surgery
  • 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.
  • Active Comparator: ordinary per operative prophylaxis
    cefuroxime(1500mg) i.v.+ metronidazole (1500mg)i.v.given at the time point of induction of anesthesia
    Intervention: Drug: cefuroxime and metronidazole
  • Experimental: Per oral alternative
    Trimethoprim-sulfamethoxazole(160mg/800mg)p.o.+metronidazole (1200mg)p.o.given 06.00 am on the day of operation
    Intervention: Drug: trimethoprim-sulfamethoxazole + metronidazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1073
May 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00613769
TSM, EudraCT number 2006-006575-20
Yes
Claes Hjalmarsson, Halmstad County Hospital
Halmstad County Hospital
Not Provided
Principal Investigator: Claes Hjalmarsson, MD,PhD Department of Surgery and Oncology, Halland Hospital Halmstad, 301 85 Halmstad, Sweden
Halmstad County Hospital
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP