Laparoscopic Versus Open Abdominal Aortic Aneurysm (AAA) Exclusion
NCT ID: NCT00821145
Last Updated: 2012-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE3
INTERVENTIONAL
2009-01-31
2010-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Total Laparoscopic Versus Open Aortic Surgery for Abdominal Aortic Disease
NCT02325700
Elective Treatment Rates and Surgical Non-eligibility Among Men and Women With Intact Abdominal Aortic Aneurysms
NCT05346289
The Altura Abdominal Aortic Aneurysm (AAA) Endograft Safety and Feasibility Study
NCT01346943
Standard Open Surgery Versus Endovascular Repair of Abdominal Aortic Aneurysm (AAA)
NCT00094575
Limb Remote Ischemic Preconditioning Reduces Heart and Lung Injury After Abdominal Aortic Aneurysm Repair
NCT01344239
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
50 patients operated using a conventional open surgery to exclude an abdominal aortic aneurysm
conventional surgery
AAA patients operated using a conventional incision
2
50 patients operated using a total laparoscopic aortic aneurysm resection
laparoscopic AAA resection
laparoscopic AAA resection
3
25 patients using a laparoscopic approach for AAA resection with a stapled proximal anastomosis
laparoscopic stapler anastomosis
laparoscopic AAA resection, proximal anastomosis performed with a stapler
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* fit for open surgery
Exclusion Criteria
* patients with malignancies
40 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Storz GmbH FRG
UNKNOWN
Tel Aviv University
OTHER
Augusta Hospital Duesseldorf
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Catholic clinics Duesseldorf
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ralf R Kolvenbach, M.D.PhD
Role: PRINCIPAL_INVESTIGATOR
Augusta Hospital Duesseldorf
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LapAorta2008
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.