Total Laparoscopic Versus Open Aortic Surgery for Abdominal Aortic Disease

Study Overview
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Brief Summary
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This prospective study was designed to analyse the postoperative and long-term outcomes of total laparoscopic vs. open surgical repair of infra-renal abdominal aortic occlusive disease (AOD) and infra-renal aortic aneurysmal disease (AAA) in comparable groups of patients using a propensity analysis model.

Detailed Description
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From January 2006 to January 2010, 228 consecutive patients who received an aortic bypass for AAA (n=139) or for AOD (n=89) were studied. Open repair was performed in145 patients (AAA=109, AOD=36) and total laparoscopic repair in 83 patients (AAA=30, AOD=53). One-to-one propensity score matching between study groups was done according to a difference in the logit of propensity score of less than 0.04 between each patient pairs in the study groups. Logistic regression with the help of backward selection was used to adjust the effect of treatment method for propensity score as well as other variables in evaluating postoperative and long-term outcome. A p value < .05 was considered statistically significant.

Official Title
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Total Laparoscopic Versus Open Aortic Surgery for Abdominal Aortic Disease. A Prospective Study With Propensity Analysis

Conditions
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Graft Occlusion, Vascular

Intervention / Treatment
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* Procedure: Aortic repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aortic occlusive disease (TASC C & D) Aortic abdominal aneurysm with a diameter > 5 cm Exclusion Criteria: Patients with an occlusive disease amenable to stenting (TASC A & B) Patients with an abdominal aortic aneurysm with an anatomy allowing the use of a stent graft (EVAR) Patients with a life expectancy < 3 years or ASA 4 with a high operative risk

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open aortic repair<br>145 patients with open aortic repair for abdominal aortic aneurysmal disease (n=139) or abdominal aortic occlusive disease (n=89) | Procedure: Aortic repair<br>* Aortic bypass<br>|
| Laparoscopic aortic repair<br>83 patients with Laparoscopic aortic repair for abdominal aortic aneurysmal disease (n=30) or abdominal aortic occlusive disease (n=53) | Procedure: Aortic repair<br>* Aortic bypass<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite adverse events (bypass occlusion, bleeding, graft infection, redo) | Any of these complications occurring during this time frame | 0 to 6 years postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Any death occurring within the first 30 days and after | 0 to 6 years postoperative |