Laparoscopic Versus Open Abdominal Aortic Aneurysm (AAA) Exclusion (LapAorta)
|Infra and Juxtarenal Abdominal Aortic Aneurysms||Procedure: conventional surgery Procedure: laparoscopic AAA resection Procedure: laparoscopic stapler anastomosis||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||Laparoscopic Aortic Resection Versus Open Surgery in Patients With AAA|
- All cause mortality, reduced recovery postoperatively according to pain measurement, ICU and hospital stay, minor and major complications [ Time Frame: 1 year ]
- Use of a stapling device reduces total operative time and crossclamping period [ Time Frame: 1 year ]
|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)|
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
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00821145
|Principal Investigator:||Ralf R Kolvenbach, M.D.PhD||Augusta Hospital Duesseldorf|