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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00615888
Other study ID # 119/2005
Secondary ID
Status Completed
Phase N/A
First received February 1, 2008
Last updated January 13, 2010
Start date September 2005
Est. completion date March 2008

Study information

Verified date September 2005
Source University of Ulm
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date March 2008
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- infrarenal aortic aneurysm

- given written informed consent

Exclusion Criteria:

- contraindication for epidural anesthesia

- suprarenal clamping

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Fast track patient management
no bowel washout, patient controlled epidural anesthesia, early enteral feeding
Traditional management
preoperative bowel washout, patient controlled analgesia, delayed start of enteral feeding

Locations

Country Name City State
Germany University of Ulm Ulm

Sponsors (1)

Lead Sponsor Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Morbidity and mortality after open infrarenal aortic aneurysm repair 2 years Yes
Secondary LOS of ICU treatment, need for postoperative mechanical ventilation, day of discharge 2 years Yes
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