Laparoscopic Versus Open Abdominal Aortic Aneurysm (AAA) Exclusion

Study Overview
=================
Brief Summary
-----------------
In many countries the gold standard for treating abdominal aortic aneurysms is still open surgery with a long incision. In patients with suitable anatomy alternatively an endovascular approach can be chosen. Since open surgery is more durable in many countries a laparoscopic procedure using  key hole surgery  has gained wider acceptance. The current study wants to prove that laparoscopic aortic aneurysm procedures are less invasive than open surgery with reduced recovery times.

Detailed Description
-----------------
In many countries the gold standard for treating abdominal aortic aneurysms is still open surgery with a long incision. In patients with suitable anatomy alternatively an endovascular approach can be chosen. Since open surgery is more durable in many countries a laparoscopic procedure using  key hole surgery  has gained wider acceptance. The current study wants to prove that laparoscopic aortic aneurysm procedures are less invasive than open surgery with reduced recovery times. Study design: Multi center prospective randomized study including patients with infra or juxtarenal aortic aneurysms ( AAA). In group I the AAA is resected using a conventional long incision and standard procedures for resecting the AAA. A Dacron graft is used in inlay technique to restore blood flow. In group II a total laparoscopic approach is chosen to exclude the AAA. Identical to open surgery a dacron graft is laparoscopically sawn in to exclude the AAA and to restore blood flow. In a subgroup II a the laparoscopic anastomosis is performed with a stapling device to simplify and to accelerate the procedure. Endpoints of the study: Total operating time, aortic crossclamping time, stay in ICU, return to a regular diet,postoperative ileus, total hospital stay, major and minor complications, blood loss, renal function in cases with juxtarenal AAA.Patients are evaluated for postoperative pain, wound related problems, hernias and time until full mobilisation is achieved. Hypothesis: The laparoscopic approach though associated with a longer operating time and longer clamping times is associated with a reduced recovery time, les pain and less wound related problems compared to a full length conventional incision.

Official Title
-----------------
Laparoscopic Aortic Resection Versus Open Surgery in Patients With AAA

Conditions
-----------------
Infra and Juxtarenal Abdominal Aortic Aneurysms

Intervention / Treatment
-----------------
* Procedure: conventional surgery
* Procedure: laparoscopic AAA resection
* Procedure: laparoscopic stapler anastomosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with abdominal aortic aneurysms fit for open surgery Exclusion Criteria: patients unfit for open surgery patients with malignancies

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>50 patients operated using a conventional open surgery to exclude an abdominal aortic aneurysm | Procedure: conventional surgery<br>* AAA patients operated using a conventional incision<br>|
| Experimental: 2<br>50 patients operated using a total laparoscopic aortic aneurysm resection | Procedure: laparoscopic AAA resection<br>* laparoscopic AAA resection<br>|
| Active Comparator: 3<br>25 patients using a laparoscopic approach for AAA resection with a stapled proximal anastomosis | Procedure: laparoscopic stapler anastomosis<br>* laparoscopic AAA resection, proximal anastomosis performed with a stapler<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality, reduced recovery postoperatively according to pain measurement, ICU and hospital stay, minor and major complications |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of a stapling device reduces total operative time and crossclamping period |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
abdominal aortic aneurysms