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
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2005
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 1, 2008
CompletedFirst Posted
Study publicly available on registry
February 14, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedJanuary 14, 2010
September 1, 2005
2.1 years
February 1, 2008
January 13, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Morbidity and mortality after open infrarenal aortic aneurysm repair
2 years
Secondary Outcomes (1)
LOS of ICU treatment, need for postoperative mechanical ventilation, day of discharge
2 years
Study Arms (2)
A
ACTIVE COMPARATORTraditional management including preoperative bowel washout, patient controlled analgesia (PCA), delayed start of enteral feeding
B
EXPERIMENTALFast track management including no bowel washout, patient controlled epidural anesthesia, early enteral feeding
Interventions
no bowel washout, patient controlled epidural anesthesia, early enteral feeding
preoperative bowel washout, patient controlled analgesia, delayed start of enteral feeding
Eligibility Criteria
You may qualify if:
- infrarenal aortic aneurysm
- given written informed consent
You may not qualify if:
- contraindication for epidural anesthesia
- suprarenal clamping
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Ulm
Ulm, 89075, Germany
Related Publications (2)
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.
PMID: 21343153DERIVEDMuehling B, Schelzig H, Steffen P, Meierhenrich R, Sunder-Plassmann L, Orend KH. A prospective randomized trial comparing traditional and fast-track patient care in elective open infrarenal aneurysm repair. World J Surg. 2009 Mar;33(3):577-85. doi: 10.1007/s00268-008-9892-2.
PMID: 19137363DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 1, 2008
First Posted
February 14, 2008
Study Start
September 1, 2005
Primary Completion
October 1, 2007
Study Completion
March 1, 2008
Last Updated
January 14, 2010
Record last verified: 2005-09