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Laparoscopic Versus Open Abdominal Aortic Aneurysm (AAA) Exclusion

NCT ID: NCT00821145

Last Updated: 2012-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-06-30

Brief Summary

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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

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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.

Conditions

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Infra and Juxtarenal Abdominal Aortic Aneurysms

Keywords

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abdominal aortic aneurysms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

conventional surgery

Intervention Type PROCEDURE

AAA patients operated using a conventional incision

2

50 patients operated using a total laparoscopic aortic aneurysm resection

Group Type EXPERIMENTAL

laparoscopic AAA resection

Intervention Type PROCEDURE

laparoscopic AAA resection

3

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

Group Type ACTIVE_COMPARATOR

laparoscopic stapler anastomosis

Intervention Type PROCEDURE

laparoscopic AAA resection, proximal anastomosis performed with a stapler

Interventions

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conventional surgery

AAA patients operated using a conventional incision

Intervention Type PROCEDURE

laparoscopic AAA resection

laparoscopic AAA resection

Intervention Type PROCEDURE

laparoscopic stapler anastomosis

laparoscopic AAA resection, proximal anastomosis performed with a stapler

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients with abdominal aortic aneurysms
* fit for open surgery

Exclusion Criteria

* patients unfit for open surgery
* patients with malignancies
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Storz GmbH FRG

UNKNOWN

Sponsor Role collaborator

Tel Aviv University

OTHER

Sponsor Role collaborator

Augusta Hospital Duesseldorf

OTHER

Sponsor Role lead

Responsible Party

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Catholic clinics Duesseldorf

Principal Investigators

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Ralf R Kolvenbach, M.D.PhD

Role: PRINCIPAL_INVESTIGATOR

Augusta Hospital Duesseldorf

Countries

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Germany

Other Identifiers

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LapAorta2008

Identifier Type: -

Identifier Source: org_study_id