Aneurysm Diameter and Surgical Outcome

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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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