Fast Track Management in Elective Open Infrarenal Aortic Aneurysm Repair

NCT ID: NCT00615888

Last Updated: 2010-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2008-03-31

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).

Conditions

Aortic Aneurysm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

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

Group Type: ACTIVE_COMPARATOR

Traditional management

Intervention Type: PROCEDURE

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

B

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

Group Type: EXPERIMENTAL

Fast track patient management

Intervention Type: PROCEDURE

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

Interventions

Fast track patient management

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

Intervention Type: PROCEDURE

Traditional management

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• infrarenal aortic aneurysm
• given written informed consent

Exclusion Criteria

• contraindication for epidural anesthesia
• suprarenal clamping

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ulm

OTHER

Sponsor Role: lead

Responsible Party

Department of Thoracic and Vascular Surgery, University of Ulm, Germany

Locations

University of Ulm

Ulm, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 21343153 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19137363 (View on PubMed)

Other Identifiers

119/2005

Identifier Type: -

Identifier Source: org_study_id