Fast Track Management in Elective Open Infrarenal Aortic Aneurysm Repair

Not Applicable

Completed

• Conditions: Aortic Aneurysm
• Interventions: Procedure: Traditional management; Procedure: Fast track patient management

• Registration Number: NCT00615888
• Lead Sponsor: University of Ulm

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 Timeline

• Status Verified: 2005-09
• Study Start: 2005-09
• Primary Completion: 2007-10
• Study First Submitted: 2008-02-01
• Study First Submitted QC: 2008-02-01
• Study First Posted: 2008-02-14
• Study Completion: 2008-03
• Last Update Submitted: 2010-01-13
• Last Update Posted: 2010-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• infrarenal aortic aneurysm
• given written informed consent

Exclusion Criteria

• contraindication for epidural anesthesia
• suprarenal clamping

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Traditional management	Traditional management including preoperative bowel washout, patient controlled analgesia (PCA), delayed start of enteral feeding
B	Fast track patient management	Fast track management including no bowel washout, patient controlled epidural anesthesia, early enteral feeding

Primary Outcome Measures

Name	Time	Method
Morbidity and mortality after open infrarenal aortic aneurysm repair	2 years

Secondary Outcome Measures

Name	Time	Method
LOS of ICU treatment, need for postoperative mechanical ventilation, day of discharge	2 years

Trial Locations

Locations (1)

University of Ulm; 🇩🇪 Ulm, Germany