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Fast Track Management in Elective Open Infrarenal Aortic Aneurysm Repair

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00615888
First Posted: February 14, 2008
Last Update Posted: January 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Ulm
  Purpose
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: None (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).
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • infrarenal aortic aneurysm
  • given written informed consent

Exclusion Criteria:

  • contraindication for epidural anesthesia
  • suprarenal clamping
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00615888


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bernd Muehling, M.D., Department of Thoracic and Vascular Surgery, University of Ulm, Germany
ClinicalTrials.gov Identifier: NCT00615888     History of Changes
Other Study ID Numbers: 119/2005
First Submitted: February 1, 2008
First Posted: February 14, 2008
Last Update Posted: January 14, 2010
Last Verified: September 2005

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

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases