Graft Occlusion, Vascular Clinical Trial
Official title:
Total Laparoscopic Versus Open Aortic Surgery for Abdominal Aortic Disease. A Prospective Study With Propensity Analysis
This prospective study was designed to analyse the postoperative and long-term outcomes of total laparoscopic vs. open surgical repair of infra-renal abdominal aortic occlusive disease (AOD) and infra-renal aortic aneurysmal disease (AAA) in comparable groups of patients using a propensity analysis model.
Status | Completed |
Enrollment | 228 |
Est. completion date | December 2014 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Aortic occlusive disease (TASC C & D) - Aortic abdominal aneurysm with a diameter > 5 cm Exclusion Criteria: - Patients with an occlusive disease amenable to stenting (TASC A & B) - Patients with an abdominal aortic aneurysm with an anatomy allowing the use of a stent graft (EVAR) - Patients with a life expectancy < 3 years or ASA 4 with a high operative risk |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Poitiers |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite adverse events (bypass occlusion, bleeding, graft infection, redo) | Any of these complications occurring during this time frame | 0 to 6 years postoperative | No |
Secondary | Mortality | Any death occurring within the first 30 days and after | 0 to 6 years postoperative | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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