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

Primary Purpose

Infection Prophylaxis in Colo Rectal Surgery

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
trimethoprim-sulfamethoxazole + metronidazole
cefuroxime and metronidazole
Sponsored by
Halmstad County Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infection Prophylaxis in Colo Rectal Surgery focused on measuring Surgical site infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Surgery, University hospital Sahlgrenska/Östra
  • Department of Surgery and oncology, Halland Hospital in Halmstad
  • Department of surgery, Community Hospital i Karlskrona
  • Vrinnevi hospital
  • Department of surgery
  • Department of Surgery, NU-hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ordinary per operative prophylaxis

Per oral alternative

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cutaneous-,subcutaneous and intraabdominal infections

Secondary Outcome Measures

Non infectious wound complications
Complications to the anastomosis
Adverse reaction of given drug
Other post operative infections
Septicaemia

Full Information

First Posted
January 31, 2008
Last Updated
September 27, 2012
Sponsor
Halmstad County Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00613769
Brief Title
Orally Administered Trimethoprim-sulfamethoxazole and Metronidazole as Prophylaxis of Infection Following 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 Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Halmstad County Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection Prophylaxis in Colo Rectal Surgery
Keywords
Surgical site infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1073 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ordinary per operative prophylaxis
Arm Type
Active Comparator
Arm Description
cefuroxime(1500mg) i.v.+ metronidazole (1500mg)i.v.given at the time point of induction of anesthesia
Arm Title
Per oral alternative
Arm Type
Experimental
Arm Description
Trimethoprim-sulfamethoxazole(160mg/800mg)p.o.+metronidazole (1200mg)p.o.given 06.00 am on the day of operation
Intervention Type
Drug
Intervention Name(s)
trimethoprim-sulfamethoxazole + metronidazole
Intervention Description
trimethoprim-sulfamethoxazole (160mg/800mg)p.o.+ metronidazole (1200mg)p.o.
Intervention Type
Drug
Intervention Name(s)
cefuroxime and metronidazole
Intervention Description
cefuromime 1500mg i.v. + metronidazole 1500mg i.v.
Primary Outcome Measure Information:
Title
Cutaneous-,subcutaneous and intraabdominal infections
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Non infectious wound complications
Time Frame
4 weeks
Title
Complications to the anastomosis
Time Frame
4 weeks
Title
Adverse reaction of given drug
Time Frame
4 weeks
Title
Other post operative infections
Time Frame
During hospital stay
Title
Septicaemia
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claes Hjalmarsson, MD,PhD
Organizational Affiliation
Department of Surgery and Oncology, Halland Hospital Halmstad, 301 85 Halmstad, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, University hospital Sahlgrenska/Östra
City
Gothenburg
ZIP/Postal Code
416 85
Country
Sweden
Facility Name
Department of Surgery and oncology, Halland Hospital in Halmstad
City
Halmstad
ZIP/Postal Code
301 85
Country
Sweden
Facility Name
Department of surgery, Community Hospital i Karlskrona
City
Karlskrona
ZIP/Postal Code
371 85
Country
Sweden
Facility Name
Vrinnevi hospital
City
Norrköping
ZIP/Postal Code
601 82
Country
Sweden
Facility Name
Department of surgery
City
Skövde
ZIP/Postal Code
541 85
Country
Sweden
Facility Name
Department of Surgery, NU-hospitals
City
Uddevalla
ZIP/Postal Code
451 80
Country
Sweden

12. IPD Sharing Statement

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

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