Fast Track Management in Elective Open Infrarenal Aortic Aneurysm Repair
| Tracking Information | |
|---|---|
| First Received Date ICMJE | February 1, 2008 |
| Last Updated Date | January 13, 2010 |
| Start Date ICMJE | September 2005 |
| Primary Completion Date | October 2007 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Morbidity and mortality after open infrarenal aortic aneurysm repair [ Time Frame: 2 years ] [ Designated as safety issue: Yes ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00615888 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
LOS of ICU treatment, need for postoperative mechanical ventilation, day of discharge [ Time Frame: 2 years ] [ Designated as safety issue: Yes ] |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Fast Track Management in Elective Open Infrarenal Aortic Aneurysm Repair |
| Official Title ICMJE | Prospective Randomized Controlled Trial to Evaluate Fast Track Recovery in Elective Open Infrarenal Aortic Aneurysm Repair |
| Brief Summary | Fast track programs have been introduced in many surgical fields to minimize postoperative morbidity and mortality. Morbidity after elective open infrarenal aneurysm repair is as high as 30%, mortality ranges up to 10%. In terms of open infrarenal aneurysm repair no randomized controlled trials exist to introduce and evaluate such patient care programs. |
| Detailed Description | Prospective randomization of patients admitted with infrarenal aortic aneurysm who undergo elective open repair in a "traditional" and "fast track" treatment arm. Main differences consist in preoperative bowel washout (none vs. 3L cleaning solution) and analgesia (patient controlled analgesia vs. patient controlled epidural analgesia: PCA vs. PCEA). Study endpoints are morbidity and mortality, need for postoperative mechanical ventilation and length of stay (LOS) on intensive care unit (ICU). |
| Study Type ICMJE | Interventional |
| Study Phase | Not Provided |
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Condition ICMJE | Aortic Aneurysm |
| Intervention ICMJE |
|
| Study Arm (s) |
|
| Publications * | Muehling BM, Ortlieb L, Oberhuber A, Orend KH. Fast track management reduces the systemic inflammatory response and organ failure following elective infrarenal aortic aneurysm repair. Interact Cardiovasc Thorac Surg. 2011 May;12(5):784-8. Epub 2011 Feb 22. |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|
| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 100 |
| Completion Date | March 2008 |
| Primary Completion Date | October 2007 (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 | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Germany |
| Administrative Information | |
| NCT Number ICMJE | NCT00615888 |
| Other Study ID Numbers ICMJE | 119/2005 |
| Has Data Monitoring Committee | Yes |
| Responsible Party | Bernd Muehling, M.D., Department of Thoracic and Vascular Surgery, University of Ulm, Germany |
| Study Sponsor ICMJE | University of Ulm |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | University of Ulm |
| Verification Date | September 2005 |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|