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NCT Number: NCT00613769

Orally Administered Trimethoprim-sulfamethoxazole 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.

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Key information

Conditions

Infection Prophylaxis in Colo Rectal Surgery Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Surgery, University hospital Sahlgrenska/Östra, Gothenburg, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

trimethoprim-sulfamethoxazole + metronidazole

Drug

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

cefuroxime and metronidazole

Drug

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

Primary outcomes

  1. Cutaneous-,subcutaneous and intraabdominal infections

    Time frame: 4 weeks

Secondary outcomes

  1. Non infectious wound complications

    Time frame: 4 weeks

  2. Complications to the anastomosis

    Time frame: 4 weeks

  3. Adverse reaction of given drug

    Time frame: 4 weeks

  4. Other post operative infections

    Time frame: During hospital stay

  5. Septicaemia

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Halmstad County Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2012
First posted
Feb 13, 2008
Registry last updated
Sep 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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