Orally Administered Trimethoprim-Sulfamethoxazole and Metronidazole as Prophylaxis of Infection Following Elective Colorectal Surgery - Tabular View

Tracking Information

First Received Date ^ICMJE

January 31, 2008

Last Updated Date

May 19, 2008

Start Date ^ICMJE

September 2007

Estimated Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Cutaneous-,subcutaneous and intraabdominal infections [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Other postoperative infections (such as pneumonia) [ Time Frame: During hospital stay ] [ Designated as safety issue: No ]
Septicaemia [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00613769 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Non infectious wound complications [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Complications to the anastomosis [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Adverse reaction of given drug [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Condition ^ICMJE

Colorectal Surgery

Intervention ^ICMJE

Drug: trimethoprim-sulfamethoxazole + metronidazole
Drug: cefuroxime and metronidazole

Study Arms / Comparison Groups

Active Comparator: cefuroxime(1500mg) i.v.+ metronidazole (1500mg)i.v.
Experimental: Trimethoprim-sulfamethoxazole(160mg/800mg)p.o.+metronidazole (1200mg)p.o.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

2000

Completion Date

Estimated Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Claes Hjalmarsson, MD,PhD

0046-35-131000

claes.hjalmarsson@lthalland.se

Location Countries ^ICMJE

Sweden

Administrative Information

NCT ID ^ICMJE

NCT00613769

Responsible Party

Claes Hjalmarsson, MD, PhD, Department of Surgery, Hospitla, Halmstad, Sweden

Study ID Numbers ^ICMJE

TSM, EudraCT number 2006-006575-20

Study Sponsor ^ICMJE

Halmstad County Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Claes Hjalmarsson, MD,PhD

Department of Surgery and Onkology, Community Hospital in Halmstad, 301 85 Halmstad, Sweden

Information Provided By

Halmstad County Hospital

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP