Brief Title
Aneurysm Diameter and Surgical Outcome
Official Title
Correlation Between the Diameter of the Infrarenal Abdominal Aortic Aneurysms Treated With Open or Endovascular Surgical and the Post-procedural Outcomes.
Brief Summary
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.
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
Observational
Primary Outcome
Correlation between Aneurysm Diameter and Open Surgery Outcome
Condition
Abdominal Aortic Aneurysm
Intervention
Open Surgery
Study Arms / Comparison Groups
Open Surgery Repair Group
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
100
Start Date
January 2, 2020
Completion Date
October 2, 2020
Primary Completion Date
September 2, 2020
Eligibility Criteria
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
Gender
All
Ages
N/A - N/A
Contacts
14743127 Serra, M.D., Ph.D., +3909613647380, [email protected]
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT04422054
Organization ID
ER.ALL.2018.19.
Responsible Party
Principal Investigator
Study Sponsor
University of Catanzaro
Study Sponsor
14743127 Serra, M.D., Ph.D., Principal Investigator, University Magna Graecia of Catanzaro
Verification Date
June 2020