Aneurysm Diameter and Surgical Outcome

NCT ID: NCT04422054

Last Updated: 2020-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-02

Study Completion Date

2020-10-02

Brief Summary

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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

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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

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Abdominal Aortic Aneurysm Surgery Outcome, Fatal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Open Surgery

Intervention Type PROCEDURE

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

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.

Endovascular Surgery

Intervention Type PROCEDURE

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

Interventions

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Open Surgery

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

Intervention Type PROCEDURE

Endovascular Surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Catanzaro

OTHER

Sponsor Role lead

Responsible Party

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Prof. Raffaele Serra, MD, Ph.D.

Associate Professor of Vascular Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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14743127 Serra, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University Magna Graecia of Catanzaro

Locations

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CIFL- Interuniversity Center of Phlebolymphology

Catanzaro, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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

Role: CONTACT

+3909613647380

Facility Contacts

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Raffaele Serra, MD

Role: primary

+393387078043

References

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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.

Reference Type BACKGROUND
PMID: 5013802 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30528142 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14743127 (View on PubMed)

Other Identifiers

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ER.ALL.2018.19.

Identifier Type: -

Identifier Source: org_study_id

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