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.
Primary Outcome Measures:
- Morbidity and mortality after open infrarenal aortic aneurysm repair [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- LOS of ICU treatment, need for postoperative mechanical ventilation, day of discharge [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Enrollment: |
100 |
| Study Start Date: |
September 2005 |
| Study Completion Date: |
January 2008 |
| Estimated Primary Completion Date: |
October 2007 (Final data collection date for primary outcome measure) |
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A: Active Comparator
Traditional management including preoperative bowel washout, patient controlled analgesia (PCA), delayed start of enteral feeding
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Procedure: Traditional management
preoperative bowel washout, patient controlled analgesia, delayed start of enteral feeding
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B: Experimental
Fast track management including no bowel washout, patient controlled epidural anesthesia, early enteral feeding
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Procedure: Fast track patient management
no bowel washout, patient controlled epidural anesthesia, early enteral feeding
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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).
Purpose
