Aneurysm Diameter and Surgical Outcome

Surgery Clinical Trial

— ADASO  

Official title:

Correlation Between the Diameter of the Infrarenal Abdominal Aortic Aneurysms Treated With Open or Endovascular Surgical and the Post-procedural Outcomes.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04422054
• Other study ID #: ER.ALL.2018.19.
• Status: Recruiting
• Start date: January 2, 2020
• Est. completion date: October 2, 2020

Study information

• Verified date: June 2020
• Source: University of Catanzaro
• Contact: Raffaele Serra, M.D., Ph.D.
• Phone: +3909613647380
• Email: rserra[@]unicz.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2, 2020
• Est. primary completion date: September 2, 2020
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Outcome, Fatal
• Surgery

Intervention

Procedure:
• Open Surgery
We will retrospectively review patients with abdominal aortic aneurysms that underwent open surgical repair.
• Endovascular Surgery
We will retrospectively review patients with abdominal aortic aneurysms that underwent endovascular repair.

Locations

Country	Name	City	State
Italy	CIFL- Interuniversity Center of Phlebolymphology	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University of Catanzaro

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Peppelenbosch N, Buth J, Harris PL, van Marrewijk C, Fransen G; EUROSTAR Collaborators. Diameter of abdominal aortic aneurysm and outcome of endovascular aneurysm repair: does size matter? A report from EUROSTAR. J Vasc Surg. 2004 Feb;39(2):288-97. — View Citation

Szilagyi DE, Elliott JP, Smith RF. Clinical fate of the patient with asymptomatic abdominal aortic aneurysm and unfit for surgical treatment. Arch Surg. 1972 Apr;104(4):600-6. — View Citation

Wanhainen A, Verzini F, Van Herzeele I, Allaire E, Bown M, Cohnert T, Dick F, van Herwaarden J, Karkos C, Koelemay M, Kölbel T, Loftus I, Mani K, Melissano G, Powell J, Szeberin Z, Esvs Guidelines Committee, de Borst GJ, Chakfe N, Debus S, Hinchliffe R, Kakkos S, Koncar I, Kolh P, Lindholt JS, de Vega M, Vermassen F, Document Reviewers, Björck M, Cheng S, Dalman R, Davidovic L, Donas K, Earnshaw J, Eckstein HH, Golledge J, Haulon S, Mastracci T, Naylor R, Ricco JB, Verhagen H. Editor's Choice - European Society for Vascular Surgery (ESVS) 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms. Eur J Vasc Endovasc Surg. 2019 Jan;57(1):8-93. doi: 10.1016/j.ejvs.2018.09.020. Epub 2018 Dec 5. Erratum in: Eur J Vasc Endovasc Surg. 2020 Mar;59(3):494. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between Aneurysm Diameter and Open Surgery Outcome	We will correlate outcomes and complications with preoperative aneurysm size.	5 years of follow up
Primary	Correlation between Aneurysm Diameter and Endovascular Repair	We will correlate outcomes and complications with preoperative aneurysm size.	5 years of follow up