Trials / Unknown
UnknownNCT04422054
Aneurysm Diameter and Surgical Outcome
Correlation Between the Diameter of the Infrarenal Abdominal Aortic Aneurysms Treated With Open or Endovascular Surgical and the Post-procedural Outcomes.
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- University of Catanzaro · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Open Surgery | We will retrospectively review patients with abdominal aortic aneurysms that underwent open surgical repair. |
| PROCEDURE | Endovascular Surgery | We will retrospectively review patients with abdominal aortic aneurysms that underwent endovascular repair. |
Timeline
- Start date
- 2020-01-02
- Primary completion
- 2020-09-02
- Completion
- 2020-10-02
- First posted
- 2020-06-09
- Last updated
- 2020-06-09
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT04422054. Inclusion in this directory is not an endorsement.