Laparoscopic Versus Open Abdominal Aortic Aneurysm (AAA) Exclusion

Last updated: July 11, 2012
Sponsor: Augusta Hospital Duesseldorf
Overall Status: Trial Not Available

Phase

3

Condition

Aneurysm

Cardiovascular Disease

Heart Disease

Treatment

N/A

Clinical Study ID

NCT00821145
LapAorta2008
  • Ages 40-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients with abdominal aortic aneurysms

  • fit for open surgery

Exclusion

Exclusion Criteria:

  • patients unfit for open surgery

  • patients with malignancies

Study Design

Study Start date:
January 01, 2009
Estimated Completion Date:
June 30, 2010

Study 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.

Connect with a study center

  • Augusta Hospital

    Duesseldorf, NRW 40472
    Germany

    Site Not Available

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