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Laparoscopic Versus Open Abdominal Aortic Aneurysm (AAA) Exclusion

Laparoscopic Aortic Resection Versus Open Surgery in Patients With AAA

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00821145
Acronym
LapAorta
Enrollment
0
Registered
2009-01-13
Start date
2009-01-31
Completion date
2010-06-30
Last updated
2012-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infra and Juxtarenal Abdominal Aortic Aneurysms

Keywords

abdominal aortic aneurysms

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.

Interventions

PROCEDUREconventional surgery

AAA patients operated using a conventional incision

PROCEDURElaparoscopic AAA resection

laparoscopic AAA resection

PROCEDURElaparoscopic stapler anastomosis

laparoscopic AAA resection, proximal anastomosis performed with a stapler

Sponsors

Storz GmbH FRG
CollaboratorUNKNOWN
Tel Aviv University
CollaboratorOTHER
Augusta Hospital Duesseldorf
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* patients with abdominal aortic aneurysms * fit for open surgery

Exclusion criteria

* patients unfit for open surgery * patients with malignancies

Design outcomes

Primary

MeasureTime frame
All cause mortality, reduced recovery postoperatively according to pain measurement, ICU and hospital stay, minor and major complications1 year

Secondary

MeasureTime frame
Use of a stapling device reduces total operative time and crossclamping period1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026