Infection Prophylaxis in Colo Rectal Surgery Clinical Trial
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
| Verified date | September 2012 |
| Source | Halmstad County Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Medical Products Agency |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1073 |
| Est. completion date | May 2012 |
| Est. primary completion date | December 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Department of Surgery, University hospital Sahlgrenska/Östra | Gothenburg | |
| Sweden | Department of Surgery and oncology, Halland Hospital in Halmstad | Halmstad | |
| Sweden | Department of surgery, Community Hospital i Karlskrona | Karlskrona | |
| Sweden | Vrinnevi hospital | Norrköping | |
| Sweden | Department of surgery | Skövde | |
| Sweden | Department of Surgery, NU-hospitals | Uddevalla |
| Lead Sponsor | Collaborator |
|---|---|
| Halmstad County Hospital |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cutaneous-,subcutaneous and intraabdominal infections | 4 weeks | No | |
| Secondary | Non infectious wound complications | 4 weeks | No | |
| Secondary | Complications to the anastomosis | 4 weeks | No | |
| Secondary | Adverse reaction of given drug | 4 weeks | Yes | |
| Secondary | Other post operative infections | During hospital stay | No | |
| Secondary | Septicaemia | 4 weeks | No |