NCT00615888

Fast Track Management in Elective Open Infrarenal Aortic Aneurysm Repair

Prospective Randomized Controlled Trial to Evaluate Fast Track Recovery in Elective Open Infrarenal Aortic Aneurysm Repair

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University of Ulm · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Aortic Aneurysm

Interventions

Type	Name	Description
PROCEDURE	Fast track patient management	no bowel washout, patient controlled epidural anesthesia, early enteral feeding
PROCEDURE	Traditional management	preoperative bowel washout, patient controlled analgesia, delayed start of enteral feeding

Timeline

• Start date: 2005-09-01
• Primary completion: 2007-10-01
• Completion: 2008-03-01
• First posted: 2008-02-14
• Last updated: 2010-01-14

Locations

1 site across 1 country: Germany