Status:
COMPLETED
Orally Administered Trimethoprim-sulfamethoxazole and Metronidazole as Prophylaxis of Infection Following Elective Colorectal Surgery
Lead Sponsor:
Halmstad County Hospital
Conditions:
Infection Prophylaxis in Colo Rectal Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- Age \>= 18 years
- Planned clean/clean-contaminated colorectal resection will be performed
- Understand spoken and written swedish language
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
1073 Patients enrolled
Trial Details
Trial ID
NCT00613769
Start Date
September 1 2007
End Date
May 1 2012
Last Update
September 28 2012
Active Locations (6)
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1
Department of Surgery, University hospital Sahlgrenska/Östra
Gothenburg, Sweden, 416 85
2
Department of Surgery and oncology, Halland Hospital in Halmstad
Halmstad, Sweden, 301 85
3
Department of surgery, Community Hospital i Karlskrona
Karlskrona, Sweden, 371 85
4
Vrinnevi hospital
Norrköping, Sweden, 601 82