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

Condition(s) targeted: Infection Prophylaxis in Colo Rectal Surgery

Intervention: trimethoprim-sulfamethoxazole + metronidazole (Drug); cefuroxime and metronidazole (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Halmstad County Hospital

Official(s) and/or principal investigator(s):
Claes Hjalmarsson, MD,PhD, Principal Investigator, Affiliation: Department of Surgery and Oncology, Halland Hospital Halmstad, 301 85 Halmstad, Sweden

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.

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Cutaneous-,subcutaneous and intraabdominal infections

Secondary outcome:

Non infectious wound complications

Complications to the anastomosis

Adverse reaction of given drug

Other post operative infections

Septicaemia

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Department of Surgery, University hospital Sahlgrenska/Östra, Gothenburg 416 85, Sweden

Department of Surgery and oncology, Halland Hospital in Halmstad, Halmstad 301 85, Sweden

Department of surgery, Community Hospital i Karlskrona, Karlskrona 371 85, Sweden

Vrinnevi hospital, Norrköping 601 82, Sweden

Department of surgery, Skövde 541 85, Sweden

Department of Surgery, NU-hospitals, Uddevalla 451 80, Sweden

Starting date: September 2007
Last updated: September 27, 2012