Aneurysm Diameter and Surgical Outcome (ADASO)

University of Catanzaro

Status: Unknown

Conditions: Surgery; Abdominal Aortic Aneurysm; Outcome, Fatal

Treatments: Procedure: Endovascular Surgery; Procedure: Open Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT04422054

ER.ALL.2018.19.

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient 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.

Treatment:

Procedure: Open Surgery

Endovascular Repair Group

Description:

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.

Treatment:

Procedure: Endovascular Surgery