Fast Track Management in Elective Open Infrarenal Aortic Aneurysm Repair

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Aortic Aneurysm

Intervention / Treatment
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* Procedure: Fast track patient management
* Procedure: Traditional management


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Traditional management including preoperative bowel washout, patient controlled analgesia (PCA), delayed start of enteral feeding | Procedure: Traditional management<br>* preoperative bowel washout, patient controlled analgesia, delayed start of enteral feeding<br>|
| Experimental: B<br>Fast track management including no bowel washout, patient controlled epidural anesthesia, early enteral feeding | Procedure: Fast track patient management<br>* no bowel washout, patient controlled epidural anesthesia, early enteral feeding<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity and mortality after open infrarenal aortic aneurysm repair |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LOS of ICU treatment, need for postoperative mechanical ventilation, day of discharge |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elective open repair, complications, morbidity and mortality, fast track patient management