Aortic Aneurysm
Conditions
Keywords
elective open repair, complications, morbidity and mortality, fast track patient management
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).
Interventions
PROCEDUREFast track patient management
no bowel washout, patient controlled epidural anesthesia, early enteral feeding
PROCEDURETraditional management
preoperative bowel washout, patient controlled analgesia, delayed start of enteral feeding
Sponsors
University of Ulm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* infrarenal aortic aneurysm * given written informed consent
Exclusion criteria
* contraindication for epidural anesthesia * suprarenal clamping
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Morbidity and mortality after open infrarenal aortic aneurysm repair | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| LOS of ICU treatment, need for postoperative mechanical ventilation, day of discharge | 2 years |
Countries
Germany
Outcome results
None listed