Aneurysm Diameter and Surgical Outcome

NCT04422054 | Unknown DMC

• 1 other identifier: ER.ALL.2018.19.
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysm; Surgery; Outcome, Fatal

Keywords

open surgery; endovascular repair; aneurysm size; outcome

Outcome Measures

Primary Outcomes (2)

• Correlation between Aneurysm Diameter and Open Surgery Outcome

  We will correlate outcomes and complications with preoperative aneurysm size.

  5 years of follow up

• Correlation between Aneurysm Diameter and Endovascular Repair

  We will correlate outcomes and complications with preoperative aneurysm size.

  5 years of follow up

Study Arms (2)

Open Surgery Repair Group

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.

Procedure: Open Surgery

Endovascular Repair Group

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.

Procedure: Endovascular Surgery

Interventions

Open Surgery PROCEDURE

We will retrospectively review patients with abdominal aortic aneurysms that underwent open surgical repair.

Open Surgery Repair Group

Endovascular Surgery PROCEDURE

We will retrospectively review patients with abdominal aortic aneurysms that underwent endovascular repair.

Endovascular Repair Group

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 patients, of both sex, with abdominal aortic aneurysm who underwent open surgery or endovascular procedures.

You may qualify if:

• 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.

You may not qualify if:

• none

Sponsors & Collaborators

• University of Catanzaro: lead

Study Sites (1)

CIFL- Interuniversity Center of Phlebolymphology

Catanzaro, 88100, Italy

RECRUITING

Related Publications (3)

• 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. doi: 10.1001/archsurg.1972.04180040214036. No abstract available.

  PMID: 5013802 BACKGROUND

• Wanhainen A, Verzini F, Van Herzeele I, Allaire E, Bown M, Cohnert T, Dick F, van Herwaarden J, Karkos C, Koelemay M, Kolbel 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, Bjorck 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. No abstract available.

  PMID: 30528142 BACKGROUND

• 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. doi: 10.1016/j.jvs.2003.09.047.

  PMID: 14743127 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Conversion to Open Surgery

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• 14743127 Serra, M.D., Ph.D.

  University Magna Graecia of Catanzaro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raffaele Serra, M.D., Ph.D.

CONTACT

+3909613647380; rserra@unicz.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Vascular Surgery

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: January 2, 2020
• Primary Completion: September 2, 2020
• Study Completion: October 2, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)