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

July 11, 2012 updated by: Augusta Hospital Duesseldorf

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with abdominal aortic aneurysms
  • fit for open surgery

Exclusion Criteria:

  • patients unfit for open surgery
  • patients with malignancies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
50 patients operated using a conventional open surgery to exclude an abdominal aortic aneurysm
Procedure: conventional surgery
AAA patients operated using a conventional incision
Experimental: 2
50 patients operated using a total laparoscopic aortic aneurysm resection
Procedure: laparoscopic AAA resection
laparoscopic AAA resection
Active Comparator: 3
25 patients using a laparoscopic approach for AAA resection with a stapled proximal anastomosis
Procedure: laparoscopic stapler anastomosis
laparoscopic AAA resection, proximal anastomosis performed with a stapler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause mortality, reduced recovery postoperatively according to pain measurement, ICU and hospital stay, minor and major complications
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Use of a stapling device reduces total operative time and crossclamping period
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augusta Hospital Duesseldorf

Collaborators

Tel Aviv University
Storz GmbH FRG

Investigators

  • Principal Investigator: Ralf R Kolvenbach, M.D.PhD, Augusta Hospital Duesseldorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

January 12, 2009

First Posted (Estimate)

January 13, 2009

Study Record Updates

Last Update Posted (Estimate)

July 12, 2012

Last Update Submitted That Met QC Criteria

July 11, 2012

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LapAorta2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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