Aneurysm Diameter and Surgical Outcome

• Conditions: Abdominal Aortic Aneurysm; Outcome, Fatal; Surgery
• Interventions: Procedure: Endovascular Surgery; Procedure: Open Surgery

• Registration Number: NCT04422054
• Lead Sponsor: University of Catanzaro

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 Timeline

• Study Start: 2020-01-02
• Status Verified: 2020-06
• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-04
• Last Update Submitted: 2020-06-04
• Study First Posted: 2020-06-09
• Last Update Posted: 2020-06-09
• Primary Completion: 2020-09-02
• Study Completion: 2020-10-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endovascular Repair Group	Endovascular Surgery	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.
Open Surgery Repair Group	Open Surgery	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.

Primary Outcome Measures

Name	Time	Method
Correlation between Aneurysm Diameter and Open Surgery Outcome	5 years of follow up	We will correlate outcomes and complications with preoperative aneurysm size.
Correlation between Aneurysm Diameter and Endovascular Repair	5 years of follow up	We will correlate outcomes and complications with preoperative aneurysm size.

Trial Locations

Locations (1)

CIFL- Interuniversity Center of Phlebolymphology; 🇮🇹 Catanzaro, Italy