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Fast Track Management in Elective Open Infrarenal Aortic Aneurysm Repair

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ClinicalTrials.gov Identifier: NCT00615888
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : January 14, 2010
Sponsor:
Information provided by:
University of Ulm

Brief 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.

Condition or disease Intervention/treatment Phase
Aortic Aneurysm Procedure: Fast track patient management Procedure: Traditional management Not Applicable

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
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
Study Start Date : September 2005
Actual Primary Completion Date : October 2007
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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 Posted: February 14, 2008    Key Record Dates
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