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
  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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00615888

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

No publications provided by University of Ulm

Additional 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
Study First Received: February 1, 2008
Last Updated: January 13, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on October 23, 2014