Laparoscopic Versus Open Abdominal Aortic Aneurysm (AAA) Exclusion (LapAorta)
Primary Purpose
Infra and Juxtarenal Abdominal Aortic Aneurysms
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
conventional surgery
laparoscopic AAA resection
laparoscopic stapler anastomosis
Sponsored by
About this trial
This is an interventional treatment trial for Infra and Juxtarenal Abdominal Aortic Aneurysms focused on measuring abdominal aortic aneurysms
Eligibility Criteria
Inclusion Criteria:
- patients with abdominal aortic aneurysms
- fit for open surgery
Exclusion Criteria:
- patients unfit for open surgery
- patients with malignancies
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Active Comparator
Arm Label
1
2
3
Arm Description
50 patients operated using a conventional open surgery to exclude an abdominal aortic aneurysm
50 patients operated using a total laparoscopic aortic aneurysm resection
25 patients using a laparoscopic approach for AAA resection with a stapled proximal anastomosis
Outcomes
Primary Outcome Measures
All cause mortality, reduced recovery postoperatively according to pain measurement, ICU and hospital stay, minor and major complications
Secondary Outcome Measures
Use of a stapling device reduces total operative time and crossclamping period
Full Information
NCT ID
NCT00821145
First Posted
January 8, 2009
Last Updated
July 11, 2012
Sponsor
Augusta Hospital Duesseldorf
Collaborators
Storz GmbH FRG, Tel Aviv University
1. Study Identification
Unique Protocol Identification Number
NCT00821145
Brief Title
Laparoscopic Versus Open Abdominal Aortic Aneurysm (AAA) Exclusion
Acronym
LapAorta
Official Title
Laparoscopic Aortic Resection Versus Open Surgery in Patients With AAA
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Withdrawn
Why Stopped
inability to recruit sufficient number of patients
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
June 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Augusta Hospital Duesseldorf
Collaborators
Storz GmbH FRG, Tel Aviv University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infra and Juxtarenal Abdominal Aortic Aneurysms
Keywords
abdominal aortic aneurysms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
50 patients operated using a conventional open surgery to exclude an abdominal aortic aneurysm
Arm Title
2
Arm Type
Experimental
Arm Description
50 patients operated using a total laparoscopic aortic aneurysm resection
Arm Title
3
Arm Type
Active Comparator
Arm Description
25 patients using a laparoscopic approach for AAA resection with a stapled proximal anastomosis
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Description
AAA patients operated using a conventional incision
Intervention Type
Procedure
Intervention Name(s)
laparoscopic AAA resection
Intervention Description
laparoscopic AAA resection
Intervention Type
Procedure
Intervention Name(s)
laparoscopic stapler anastomosis
Intervention Description
laparoscopic AAA resection, proximal anastomosis performed with a stapler
Primary Outcome Measure Information:
Title
All cause mortality, reduced recovery postoperatively according to pain measurement, ICU and hospital stay, minor and major complications
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Use of a stapling device reduces total operative time and crossclamping period
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with abdominal aortic aneurysms
fit for open surgery
Exclusion Criteria:
patients unfit for open surgery
patients with malignancies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralf R Kolvenbach, M.D.PhD
Organizational Affiliation
Augusta Hospital Duesseldorf
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Laparoscopic Versus Open Abdominal Aortic Aneurysm (AAA) Exclusion
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