Clinical trial NCT00821145: Laparoscopic Versus Open Abdominal Aortic Aneurysm (AAA) Exclusion
Official title: Laparoscopic Aortic Resection Versus Open Surgery in Patients With AAA
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Infra and Juxtarenal Abdominal Aortic Aneurysms
Keywords: abdominal aortic aneurysms
Lead sponsor: Augusta Hospital Duesseldorf
Sponsor class: OTHER
Collaborators: name: Storz GmbH FRG
name: Tel Aviv University
First posted: 2009-01-13
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* patients with abdominal aortic aneurysms
* fit for open surgery

Exclusion Criteria:

* patients unfit for open surgery
* patients with malignancies

Primary outcomes:
measure: All cause mortality, reduced recovery postoperatively according to pain measurement, ICU and hospital stay, minor and major complications
timeFrame: 1 year
Secondary outcomes:
measure: Use of a stapling device reduces total operative time and crossclamping period
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Augusta Hospital Duesseldorf
name: Ralf R Kolvenbach, M.D.PhD
role: PRINCIPAL_INVESTIGATOR
References: