|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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 |
|
||||
| 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 |
|
||||
| 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 |
|
||||
| Study Arms / Comparison Groups |
|
||||
| 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:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
|
||||
| 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 |
|
||||
| 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 |
|||||