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

Phase 4

Completed

• Conditions: Infection Prophylaxis in Colo Rectal Surgery
• Interventions: Drug: cefuroxime and metronidazole; Drug: trimethoprim-sulfamethoxazole + metronidazole

• Registration Number: NCT00613769
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-01-31
• Study First Submitted QC: 2008-01-31
• Study First Posted: 2008-02-13
• Primary Completion: 2011-12
• Study Completion: 2012-05
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-27
• Last Update Posted: 2012-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1073

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ordinary per operative prophylaxis	cefuroxime and metronidazole	cefuroxime(1500mg) i.v.+ metronidazole (1500mg)i.v.given at the time point of induction of anesthesia
Per oral alternative	trimethoprim-sulfamethoxazole + metronidazole	Trimethoprim-sulfamethoxazole(160mg/800mg)p.o.+metronidazole (1200mg)p.o.given 06.00 am on the day of operation

Primary Outcome Measures

Name	Time	Method
Cutaneous-,subcutaneous and intraabdominal infections	4 weeks

Secondary Outcome Measures

Name	Time	Method
Septicaemia	4 weeks
Non infectious wound complications	4 weeks
Other post operative infections	During hospital stay
Complications to the anastomosis	4 weeks
Adverse reaction of given drug	4 weeks

Trial Locations

Locations (6)

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, Sweden