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

NCT ID: NCT00613769

Last Updated: 2012-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1073 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2012-05-31

Brief Summary

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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

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Conditions

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Infection Prophylaxis in Colo Rectal Surgery

Keywords

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Surgical site infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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ordinary per operative prophylaxis

cefuroxime(1500mg) i.v.+ metronidazole (1500mg)i.v.given at the time point of induction of anesthesia

Group Type ACTIVE_COMPARATOR

cefuroxime and metronidazole

Intervention Type DRUG

cefuromime 1500mg i.v. + metronidazole 1500mg i.v.

Per oral alternative

Trimethoprim-sulfamethoxazole(160mg/800mg)p.o.+metronidazole (1200mg)p.o.given 06.00 am on the day of operation

Group Type EXPERIMENTAL

trimethoprim-sulfamethoxazole + metronidazole

Intervention Type DRUG

trimethoprim-sulfamethoxazole (160mg/800mg)p.o.+ metronidazole (1200mg)p.o.

Interventions

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trimethoprim-sulfamethoxazole + metronidazole

trimethoprim-sulfamethoxazole (160mg/800mg)p.o.+ metronidazole (1200mg)p.o.

Intervention Type DRUG

cefuroxime and metronidazole

cefuromime 1500mg i.v. + metronidazole 1500mg i.v.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Halmstad County Hospital

OTHER

Sponsor Role lead

Responsible Party

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Claes Hjalmarsson

MDPhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claes Hjalmarsson, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery and Oncology, Halland Hospital Halmstad, 301 85 Halmstad, Sweden

Locations

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Department of Surgery, University hospital Sahlgrenska/Östra

Gothenburg, , Sweden

Site Status

Department of Surgery and oncology, Halland Hospital in Halmstad

Halmstad, , Sweden

Site Status

Department of surgery, Community Hospital i Karlskrona

Karlskrona, , Sweden

Site Status

Vrinnevi hospital

Norrköping, , Sweden

Site Status

Department of surgery

Skövde, , Sweden

Site Status

Department of Surgery, NU-hospitals

Uddevalla, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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EudraCT number 2006-006575-20

Identifier Type: -

Identifier Source: secondary_id

TSM

Identifier Type: -

Identifier Source: org_study_id