Clinical trial NCT00613769: Orally Administered Trimethoprim-sulfamethoxazole and Metronidazole as Prophylaxis of Infection Following Elective Colorectal Surgery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infection Prophylaxis in Colo Rectal Surgery
Keywords: Surgical site infections
Lead sponsor: Halmstad County Hospital
Sponsor class: OTHER
First posted: 2008-02-13
Enrollment: 1073
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cutaneous-,subcutaneous and intraabdominal infections
timeFrame: 4 weeks
Secondary outcomes:
measure: Non infectious wound complications
timeFrame: 4 weeks
measure: Complications to the anastomosis
timeFrame: 4 weeks
measure: Adverse reaction of given drug
timeFrame: 4 weeks
measure: Other post operative infections
timeFrame: During hospital stay
measure: Septicaemia
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Department of Surgery, University hospital Sahlgrenska/Östra
city: Halmstad
country: Sweden
facility: Department of Surgery and oncology, Halland Hospital in Halmstad
city: Karlskrona
country: Sweden
facility: Department of surgery, Community Hospital i Karlskrona
city: Norrköping
country: Sweden
facility: Vrinnevi hospital
city: Skövde
country: Sweden
facility: Department of surgery
city: Uddevalla
country: Sweden
facility: Department of Surgery, NU-hospitals
Study officials:
affiliation: Department of Surgery and Oncology, Halland Hospital Halmstad, 301 85 Halmstad, Sweden
name: Claes Hjalmarsson, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: