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Fast Track Management in Elective Open Infrarenal Aortic Aneurysm Repair

Primary Purpose

Aortic Aneurysm

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Fast track patient management

Traditional management

About this trial

This is an interventional treatment trial for Aortic Aneurysm focused on measuring elective open repair, complications, morbidity and mortality, fast track patient management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

infrarenal aortic aneurysm
given written informed consent

Exclusion Criteria:

contraindication for epidural anesthesia
suprarenal clamping

Sites / Locations

University of Ulm

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

Traditional management including preoperative bowel washout, patient controlled analgesia (PCA), delayed start of enteral feeding

Fast track management including no bowel washout, patient controlled epidural anesthesia, early enteral feeding

Outcomes

Primary Outcome Measures

Morbidity and mortality after open infrarenal aortic aneurysm repair

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00615888

First Posted

February 1, 2008

Last Updated

January 13, 2010

Sponsor

University of Ulm

1. Study Identification

Unique Protocol Identification Number

NCT00615888

Brief Title

Fast Track Management in Elective Open Infrarenal Aortic Aneurysm Repair

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Ulm

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Aneurysm

Keywords

elective open repair, complications, morbidity and mortality, fast track patient management

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Traditional management including preoperative bowel washout, patient controlled analgesia (PCA), delayed start of enteral feeding

Arm Title

Arm Type

Experimental

Arm Description

Fast track management including no bowel washout, patient controlled epidural anesthesia, early enteral feeding

Intervention Type

Procedure

Intervention Name(s)

Fast track patient management

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Traditional management

Intervention Description

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

Primary Outcome Measure Information:

Title

Morbidity and mortality after open infrarenal aortic aneurysm repair

Time Frame

2 years

Secondary Outcome Measure Information:

Title

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

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: infrarenal aortic aneurysm given written informed consent Exclusion Criteria: contraindication for epidural anesthesia suprarenal clamping

Facility Information:

Facility Name

University of Ulm

City

Ulm

ZIP/Postal Code

89075

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

21343153

Citation

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.

Results Reference

derived

PubMed Identifier

19137363

Citation

Muehling 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.

Results Reference

derived

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Fast Track Management in Elective Open Infrarenal Aortic Aneurysm Repair

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