Aneurysm Diameter and Surgical Outcome (ADASO)
Correlation Between the Diameter of the Infrarenal Abdominal Aortic Aneurysms Treated With Open or Endovascular Surgical and the Post-procedural Outcomes.
Aneurysm diameter is an important risk for rupture and related death in affected patients.
This study will evaluate whether aneurysms size may even influence post procedural outcomes both in open surgical repair and in end-vascular aneurysm repair.
We will retrospectively review clinical data of operated patients with abdominal aortic aneurysm. We will consider both open surgical repair and endovascular aneurysm repair procedures in order to assess the influence of aneurysm size at the time of intervention.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Since the publication by Szilagyi et al, size of aneurysms has been recognized as the predominant risk factor for rupture. In fact, a low risk is associated with small aneurysms, an intermediate risk with medium-sized aneurysms, and dramatically an increased risk with large aneurysms. Current guidelines suggest that the threshold diameter for aneurysm surgery being 5.5 cm for male patients and 5.0 cm for female patients, as measured on the largest section of the aneurysm.
The correlation aneurysm diameter may also have an impact on early and late postoperative outcomes both for open surgery and endovascular surgery. The study by Peppelenbosch N et al. showed that size differences were strongly associated with adverse outcomes during follow-up of patients that underwent endovascular aneurysm repair.
The aim of this is to assess the influence of aneurysm size on the early and late outcomes of open surgical repair (OSR) and endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAA).
Preoperative patient characteristics, comorbid conditions, aneurysm anatomy and diameters will be retrospectively reviewed in order to correlate with the results of the procedures (OSR and EVAR) and with adverse outcome that may have been occurred during follow up.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Catanzaro, Italy, 88100
- Recruiting
- CIFL- Interuniversity Center of Phlebolymphology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients with abdominal aortic aneurysm who underwent open surgery or endovascular procedures with complete anatomic data of aneurysms and clinical data with a minimus of 5 years of follow up.
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Open Surgery Repair Group
In the open surgery repair group, preoperative patient characteristics, comorbid conditions, aneurysm anatomy and diameters will be matched with outcomes and complications, in the postoperative period, during follow up.
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We will retrospectively review patients with abdominal aortic aneurysms that underwent open surgical repair.
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Endovascular Repair Group
In the endovascular surgery repair group, preoperative patient characteristics, comorbid conditions, aneurysm anatomy and diameters will be matched with outcomes and complications in the postoperative period, during follow up.
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We will retrospectively review patients with abdominal aortic aneurysms that underwent endovascular repair.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Correlation between Aneurysm Diameter and Open Surgery Outcome
Time Frame: 5 years of follow up
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We will correlate outcomes and complications with preoperative aneurysm size.
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5 years of follow up
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Correlation between Aneurysm Diameter and Endovascular Repair
Time Frame: 5 years of follow up
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We will correlate outcomes and complications with preoperative aneurysm size.
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5 years of follow up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: 14743127 Serra, M.D., Ph.D., University Magna Graecia of Catanzaro
Publications and helpful links
General Publications
- Wanhainen A, Verzini F, Van Herzeele I, Allaire E, Bown M, Cohnert T, Dick F, van Herwaarden J, Karkos C, Koelemay M, Kolbel T, Loftus I, Mani K, Melissano G, Powell J, Szeberin Z, Esvs Guidelines Committee, de Borst GJ, Chakfe N, Debus S, Hinchliffe R, Kakkos S, Koncar I, Kolh P, Lindholt JS, de Vega M, Vermassen F, Document Reviewers, Bjorck M, Cheng S, Dalman R, Davidovic L, Donas K, Earnshaw J, Eckstein HH, Golledge J, Haulon S, Mastracci T, Naylor R, Ricco JB, Verhagen H. Editor's Choice - European Society for Vascular Surgery (ESVS) 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms. Eur J Vasc Endovasc Surg. 2019 Jan;57(1):8-93. doi: 10.1016/j.ejvs.2018.09.020. Epub 2018 Dec 5. No abstract available. Erratum In: Eur J Vasc Endovasc Surg. 2020 Mar;59(3):494.
- Szilagyi DE, Elliott JP, Smith RF. Clinical fate of the patient with asymptomatic abdominal aortic aneurysm and unfit for surgical treatment. Arch Surg. 1972 Apr;104(4):600-6. doi: 10.1001/archsurg.1972.04180040214036. No abstract available.
- Peppelenbosch N, Buth J, Harris PL, van Marrewijk C, Fransen G; EUROSTAR Collaborators. Diameter of abdominal aortic aneurysm and outcome of endovascular aneurysm repair: does size matter? A report from EUROSTAR. J Vasc Surg. 2004 Feb;39(2):288-97. doi: 10.1016/j.jvs.2003.09.047.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ER.ALL.2018.19.
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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