Prospective Randomized Controlled Trial to Evaluate Fast Track Recovery in Elective Open Infrarenal Aortic Aneurysm Repair
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Aneurysm
- Sponsor
- University of Ulm
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Morbidity and mortality after open infrarenal aortic aneurysm repair
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •infrarenal aortic aneurysm
- •given written informed consent
Exclusion Criteria
- •contraindication for epidural anesthesia
- •suprarenal clamping
Outcomes
Primary Outcomes
Morbidity and mortality after open infrarenal aortic aneurysm repair
Time Frame: 2 years
Secondary Outcomes
- LOS of ICU treatment, need for postoperative mechanical ventilation, day of discharge(2 years)