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

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

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.

Study Overview

• Status: Completed
• Conditions: Infection Prophylaxis in Colo Rectal Surgery
• Intervention / Treatment: Drug: cefuroxime and metronidazole; Drug: trimethoprim-sulfamethoxazole + metronidazole

• Study Type: Interventional
• Enrollment (Actual): 1073
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 416 85
    • Department of Surgery, University hospital Sahlgrenska/Östra
  • Halmstad, Sweden, 301 85
    • Department of Surgery and oncology, Halland Hospital in Halmstad
  • Karlskrona, Sweden, 371 85
    • Department of surgery, Community Hospital i Karlskrona
  • Norrköping, Sweden, 601 82
    • Vrinnevi Hospital
  • Skövde, Sweden, 541 85
    • Department of Surgery
  • Uddevalla, Sweden, 451 80
    • Department of Surgery, NU-hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cutaneous-,subcutaneous and intraabdominal infections	4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Halmstad County Hospital
• Investigators: Principal Investigator: Claes Hjalmarsson, MD,PhD, Department of Surgery and Oncology, Halland Hospital Halmstad, 301 85 Halmstad, Sweden

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): May 1, 2012

Study Registration Dates

• First Submitted: January 31, 2008
• First Submitted That Met QC Criteria: January 31, 2008
• First Posted (ESTIMATE): February 13, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): September 28, 2012
• Last Update Submitted That Met QC Criteria: September 27, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Surgical site infections
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Folic Acid Antagonists; Anti-Dyskinesia Agents; Anti-Infective Agents, Urinary; Renal Agents; Cytochrome P-450 CYP2C8 Inhibitors; Metronidazole; Trimethoprim; Sulfamethoxazole; Trimethoprim, Sulfamethoxazole Drug Combination; Cefuroxime; Cefuroxime axetil
• Other Study ID Numbers: TSM; EudraCT number 2006-006575-20