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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00613769
Recruitment Status : Completed
First Posted : February 13, 2008
Last Update Posted : September 28, 2012
Information provided by (Responsible Party):
Claes Hjalmarsson, Halmstad County Hospital

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.

Condition or disease Intervention/treatment Phase
Infection Prophylaxis in Colo Rectal Surgery Drug: trimethoprim-sulfamethoxazole + metronidazole Drug: cefuroxime and metronidazole Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1073 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Study Start Date : September 2007
Actual Primary Completion Date : December 2011
Actual Study Completion Date : May 2012

Arm Intervention/treatment
Active Comparator: ordinary per operative prophylaxis
cefuroxime(1500mg) i.v.+ metronidazole (1500mg)i.v.given at the time point of induction of anesthesia
Drug: cefuroxime and metronidazole
cefuromime 1500mg i.v. + metronidazole 1500mg i.v.

Experimental: Per oral alternative
Trimethoprim-sulfamethoxazole(160mg/800mg)p.o.+metronidazole (1200mg)p.o.given 06.00 am on the day of operation
Drug: trimethoprim-sulfamethoxazole + metronidazole
trimethoprim-sulfamethoxazole (160mg/800mg)p.o.+ metronidazole (1200mg)p.o.

Primary Outcome Measures :
  1. Cutaneous-,subcutaneous and intraabdominal infections [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00613769

Department of Surgery, University hospital Sahlgrenska/Östra
Gothenburg, Sweden, 416 85
Department of Surgery and oncology, Halland Hospital in Halmstad
Halmstad, Sweden, 301 85
Department of surgery, Community Hospital i Karlskrona
Karlskrona, Sweden, 371 85
Vrinnevi hospital
Norrköping, Sweden, 601 82
Department of surgery
Skövde, Sweden, 541 85
Department of Surgery, NU-hospitals
Uddevalla, Sweden, 451 80
Sponsors and Collaborators
Halmstad County Hospital
Principal Investigator: Claes Hjalmarsson, MD,PhD Department of Surgery and Oncology, Halland Hospital Halmstad, 301 85 Halmstad, Sweden

Responsible Party: Claes Hjalmarsson, MDPhD, Halmstad County Hospital Identifier: NCT00613769     History of Changes
Other Study ID Numbers: TSM
EudraCT number 2006-006575-20
First Posted: February 13, 2008    Key Record Dates
Last Update Posted: September 28, 2012
Last Verified: September 2012

Keywords provided by Claes Hjalmarsson, Halmstad County Hospital:
Surgical site infections

Additional relevant MeSH terms:
Communicable Diseases
Cefuroxime axetil
Trimethoprim, Sulfamethoxazole Drug Combination
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents, Urinary
Renal Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Bacterial Agents