Fast Track Management in Elective Open Infrarenal Aortic Aneurysm Repair

This study has been completed.
Sponsor:
Information provided by:
University of Ulm
ClinicalTrials.gov Identifier:
NCT00615888
First received: February 1, 2008
Last updated: January 13, 2010
Last verified: September 2005

February 1, 2008
January 13, 2010
September 2005
October 2007   (final data collection date for primary outcome measure)
Morbidity and mortality after open infrarenal aortic aneurysm repair [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00615888 on ClinicalTrials.gov Archive Site
LOS of ICU treatment, need for postoperative mechanical ventilation, day of discharge [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Fast Track Management in Elective Open Infrarenal Aortic Aneurysm Repair
Prospective Randomized Controlled Trial to Evaluate Fast Track Recovery in Elective Open Infrarenal Aortic Aneurysm Repair

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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Aortic Aneurysm
  • Procedure: Fast track patient management
    no bowel washout, patient controlled epidural anesthesia, early enteral feeding
  • Procedure: Traditional management
    preoperative bowel washout, patient controlled analgesia, delayed start of enteral feeding
  • Active Comparator: A
    Traditional management including preoperative bowel washout, patient controlled analgesia (PCA), delayed start of enteral feeding
    Intervention: Procedure: Traditional management
  • Experimental: B
    Fast track management including no bowel washout, patient controlled epidural anesthesia, early enteral feeding
    Intervention: Procedure: Fast track patient management
Muehling BM, Ortlieb L, Oberhuber A, Orend KH. Fast track management reduces the systemic inflammatory response and organ failure following elective infrarenal aortic aneurysm repair. Interact Cardiovasc Thorac Surg. 2011 May;12(5):784-8. doi: 10.1510/icvts.2010.262337. Epub 2011 Feb 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
March 2008
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • infrarenal aortic aneurysm
  • given written informed consent

Exclusion Criteria:

  • contraindication for epidural anesthesia
  • suprarenal clamping
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00615888
119/2005
Yes
Bernd Muehling, M.D., Department of Thoracic and Vascular Surgery, University of Ulm, Germany
University of Ulm
Not Provided
Not Provided
University of Ulm
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP