Fast Track Management in Elective Open Infrarenal Aortic Aneurysm Repair

Aortic Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00615888
• Other study ID #: 119/2005
• Status: Completed
• Phase: N/A
• First received: February 1, 2008
• Last updated: January 13, 2010
• Start date: September 2005
• Est. completion date: March 2008

Study information

• Verified date: September 2005
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• infrarenal aortic aneurysm

• given written informed consent

Exclusion Criteria:

• contraindication for epidural anesthesia

• suprarenal clamping

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm

Intervention

Procedure:
• Fast track patient management
no bowel washout, patient controlled epidural anesthesia, early enteral feeding
• Traditional management
preoperative bowel washout, patient controlled analgesia, delayed start of enteral feeding

Locations

Country	Name	City	State
Germany	University of Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity and mortality after open infrarenal aortic aneurysm repair		2 years	Yes
Secondary	LOS of ICU treatment, need for postoperative mechanical ventilation, day of discharge		2 years	Yes