Infra and Juxtarenal Abdominal Aortic Aneurysms Clinical Trial
Official title:
Laparoscopic Aortic Resection Versus Open Surgery in Patients With AAA
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment