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Fast Track Management in Elective Open Infrarenal Aortic Aneurysm Repair

This study has been completed.
Information provided by:
University of Ulm Identifier:
First received: February 1, 2008
Last updated: January 13, 2010
Last verified: September 2005
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.

Condition Intervention
Aortic Aneurysm
Procedure: Fast track patient management
Procedure: Traditional management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Trial to Evaluate Fast Track Recovery in Elective Open Infrarenal Aortic Aneurysm Repair

Resource links provided by NLM:

Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • Morbidity and mortality after open infrarenal aortic aneurysm repair [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • LOS of ICU treatment, need for postoperative mechanical ventilation, day of discharge [ Time Frame: 2 years ]

Enrollment: 100
Study Start Date: September 2005
Study Completion Date: March 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Traditional management including preoperative bowel washout, patient controlled analgesia (PCA), delayed start of enteral feeding
Procedure: Traditional management
preoperative bowel washout, patient controlled analgesia, delayed start of enteral feeding
Experimental: B
Fast track management including no bowel washout, patient controlled epidural anesthesia, early enteral feeding
Procedure: Fast track patient management
no bowel washout, patient controlled epidural anesthesia, early enteral feeding

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).

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • infrarenal aortic aneurysm
  • given written informed consent

Exclusion Criteria:

  • contraindication for epidural anesthesia
  • suprarenal clamping
  Contacts and Locations
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Please refer to this study by its identifier: NCT00615888

University of Ulm
Ulm, Germany, 89075
Sponsors and Collaborators
University of Ulm
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bernd Muehling, M.D., Department of Thoracic and Vascular Surgery, University of Ulm, Germany Identifier: NCT00615888     History of Changes
Other Study ID Numbers: 119/2005
Study First Received: February 1, 2008
Last Updated: January 13, 2010

Keywords provided by University of Ulm:
elective open repair
morbidity and mortality
fast track patient management

Additional relevant MeSH terms:
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases processed this record on May 25, 2017