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

This study has been withdrawn prior to enrollment.
(inability to recruit sufficient number of patients)
Sponsor:
Collaborators:
Storz GmbH FRG
Tel Aviv University
Information provided by:
Augusta Hospital Duesseldorf
ClinicalTrials.gov Identifier:
NCT00821145
First received: January 8, 2009
Last updated: July 11, 2012
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Infra and Juxtarenal Abdominal Aortic Aneurysms
Procedure: conventional surgery
Procedure: laparoscopic AAA resection
Procedure: laparoscopic stapler anastomosis
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Laparoscopic Aortic Resection Versus Open Surgery in Patients With AAA

Resource links provided by NLM:


Further study details as provided by Augusta Hospital Duesseldorf:

Primary Outcome Measures:
  • All cause mortality, reduced recovery postoperatively according to pain measurement, ICU and hospital stay, minor and major complications [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Use of a stapling device reduces total operative time and crossclamping period [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with abdominal aortic aneurysms
  • fit for open surgery

Exclusion Criteria:

  • patients unfit for open surgery
  • patients with malignancies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821145

Sponsors and Collaborators
Augusta Hospital Duesseldorf
Storz GmbH FRG
Tel Aviv University
Investigators
Principal Investigator: Ralf R Kolvenbach, M.D.PhD Augusta Hospital Duesseldorf
  More Information

No publications provided

Responsible Party: Ralf Kolvenbach, Prof. M.D., Catholic clinics Duesseldorf
ClinicalTrials.gov Identifier: NCT00821145     History of Changes
Other Study ID Numbers: LapAorta2008
Study First Received: January 8, 2009
Last Updated: July 11, 2012
Health Authority: Germany: Ministry of Health

Keywords provided by Augusta Hospital Duesseldorf:
abdominal aortic aneurysms

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on August 28, 2014