Laparoscopic Versus Open Abdominal Aortic Aneurysm (AAA) Exclusion (LapAorta)

Augusta Hospital Duesseldorf

Status and phase: Withdrawn; Phase 3

Conditions: Infra and Juxtarenal Abdominal Aortic Aneurysms

Treatments: Procedure: conventional surgery; Procedure: laparoscopic AAA resection; Procedure: laparoscopic stapler anastomosis

Study type: Interventional

Funder types: Other

Identifiers

NCT00821145

LapAorta2008

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with abdominal aortic aneurysms
• fit for open surgery

Exclusion criteria

• patients unfit for open surgery
• patients with malignancies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 3 patient groups

1

Active Comparator group

Description:

50 patients operated using a conventional open surgery to exclude an abdominal aortic aneurysm

Treatment:

Procedure: conventional surgery

2

Experimental group

Description:

50 patients operated using a total laparoscopic aortic aneurysm resection

Treatment:

Procedure: laparoscopic AAA resection

3

Active Comparator group

Description:

25 patients using a laparoscopic approach for AAA resection with a stapled proximal anastomosis

Treatment:

Procedure: laparoscopic stapler anastomosis