Laparoscopic Versus Open Abdominal Aortic Aneurysm (AAA) Exclusion

Phase 3

Withdrawn

• Conditions: Infra and Juxtarenal Abdominal Aortic Aneurysms
• Interventions: Procedure: conventional surgery; Procedure: laparoscopic AAA resection; Procedure: laparoscopic stapler anastomosis

• Registration Number: NCT00821145
• Lead Sponsor: Augusta Hospital Duesseldorf

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.

Study Timeline

• Status Verified: 2009-01
• Study Start: 2009-01
• Study First Submitted: 2009-01-08
• Study First Submitted QC: 2009-01-12
• Study First Posted: 2009-01-13
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Last Update Submitted: 2012-07-11
• Last Update Posted: 2012-07-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• patients with abdominal aortic aneurysms
• fit for open surgery

Exclusion Criteria

• patients unfit for open surgery
• patients with malignancies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	conventional surgery	50 patients operated using a conventional open surgery to exclude an abdominal aortic aneurysm
2	laparoscopic AAA resection	50 patients operated using a total laparoscopic aortic aneurysm resection
3	laparoscopic stapler anastomosis	25 patients using a laparoscopic approach for AAA resection with a stapled proximal anastomosis

Primary Outcome Measures

Name	Time	Method
All cause mortality, reduced recovery postoperatively according to pain measurement, ICU and hospital stay, minor and major complications	1 year

Secondary Outcome Measures

Name	Time	Method
Use of a stapling device reduces total operative time and crossclamping period	1 year