Fast Track Management in Elective Open Infrarenal Aortic Aneurysm Repair

University of Ulm

Status: Completed

Conditions: Aortic Aneurysm

Treatments: Procedure: Traditional management; Procedure: Fast track patient management

Study type: Interventional

Funder types: Other

Identifiers

NCT00615888

119/2005

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• infrarenal aortic aneurysm
• given written informed consent

Exclusion criteria

• contraindication for epidural anesthesia
• suprarenal clamping

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

A

Active Comparator group

Description:

Traditional management including preoperative bowel washout, patient controlled analgesia (PCA), delayed start of enteral feeding

Treatment:

Procedure: Traditional management

B

Experimental group

Description:

Fast track management including no bowel washout, patient controlled epidural anesthesia, early enteral feeding

Treatment:

Procedure: Fast track patient management