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OpenTrials
Completed

NCT Number: NCT00615888

Fast Track Management 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.

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Key information

Conditions

Aortic Aneurysm Aneurysm Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ulm

Ulm, 89075, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • infrarenal aortic aneurysm
  • given written informed consent

Exclusion criteria

  • contraindication for epidural anesthesia
  • suprarenal clamping

Treatment and study plan

Fast track patient management

Procedure

no bowel washout, patient controlled epidural anesthesia, early enteral feeding

Traditional management

Procedure

preoperative bowel washout, patient controlled analgesia, delayed start of enteral feeding

Primary outcomes

  1. Morbidity and mortality after open infrarenal aortic aneurysm repair

    Time frame: 2 years

Secondary outcomes

  1. LOS of ICU treatment, need for postoperative mechanical ventilation, day of discharge

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Registry information

Official study title

Prospective Randomized Controlled Trial to Evaluate Fast Track Recovery in Elective Open Infrarenal Aortic Aneurysm Repair

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Feb 14, 2008
Registry last updated
Jan 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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