Laparoscopic Versus Open Abdominal Aortic Aneurysm (AAA) Exclusion

Infra and Juxtarenal Abdominal Aortic Aneurysms Clinical Trial

— LapAorta  

Official title:

Laparoscopic Aortic Resection Versus Open Surgery in Patients With AAA

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00821145
• Other study ID #: LapAorta2008
• Status: Withdrawn
• Phase: Phase 3
• First received: January 8, 2009
• Last updated: July 11, 2012
• Start date: January 2009
• Est. completion date: June 2010

Study information

• Verified date: January 2009
• Source: Augusta Hospital Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients with abdominal aortic aneurysms

• fit for open surgery

Exclusion Criteria:

• patients unfit for open surgery

• patients with malignancies

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Infra and Juxtarenal Abdominal Aortic Aneurysms

Intervention

Procedure:
• conventional surgery
AAA patients operated using a conventional incision
• laparoscopic AAA resection
laparoscopic AAA resection
• laparoscopic stapler anastomosis
laparoscopic AAA resection, proximal anastomosis performed with a stapler

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Augusta Hospital Duesseldorf	Storz GmbH FRG, Tel Aviv University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality, reduced recovery postoperatively according to pain measurement, ICU and hospital stay, minor and major complications		1 year	No
Secondary	Use of a stapling device reduces total operative time and crossclamping period		1 year	No