Postoperative surveillance and long-term outcome after endovascular aortic aneurysm repair in the Netherlands: study protocol for the retrospective ODYSSEUS study.
Adolescent
Adult
Aged
Aorta, Abdominal
/ pathology
Aortic Aneurysm, Abdominal
/ mortality
Aortic Rupture
/ mortality
Attitude of Health Personnel
Computed Tomography Angiography
Endovascular Procedures
/ adverse effects
Female
Follow-Up Studies
Humans
Male
Middle Aged
Netherlands
Patient Care
/ methods
Patient Selection
Postoperative Complications
/ diagnosis
Renal Artery
/ pathology
Research Design
Retrospective Studies
Risk Assessment
/ methods
Ultrasonography
Young Adult
aortic aneurysm, abdominal
endovascular procedures
vascular surgery
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
18 02 2020
18 02 2020
Historique:
entrez:
21
2
2020
pubmed:
23
2
2020
medline:
17
2
2021
Statut:
epublish
Résumé
Strict imaging surveillance protocols to detect complications following endovascular aneurysm repair (EVAR) are common practice. However, controversy exists as to whether all EVAR patients need intense surveillance. The 2019 European Society for Vascular Surgery guidelines for management of abdominal aortic aneurysm (AAA) suggest that patients may be considered for limited follow-up with imaging if classified as 'low risk' for complications based on their initial postoperative imaging. The current study aims to investigate the intervention-free survival and overall survival stratified for patients with and without yearly imaging surveillance. The Observing a Decade of Yearly Standardised Surveillance in EVAR patients with Ultrasound or CT Scan study comprises a national multicentre retrospective cohort study in 17 medical centres. Consecutive patients with an asymptomatic or symptomatic infrarenal AAA who underwent EVAR between January 2007 and January 2012 will be included in this study with follow-up until December 2018. Clinical variables and all follow-up information will be retrieved in extensive data collection from the patient's medical records. In addition, an e-survey was sent to vascular surgeons at the 17 participating centres to gauge their opinions regarding the possibility of safely reducing the frequency of imaging surveillance. Primary endpoints are intervention after EVAR and aneurysm-related mortality. The initial estimated sample size is 1997 patients. The study has been approved by the Medical Ethics Review Committee of the Amsterdam UMC, location Academic Medical Centre, Amsterdam, the Netherlands. Study findings will be disseminated via presentations at conferences and publications in peer-reviewed journal. The Netherlands Trial Registry, NL6953 (old: NTR28773).
Identifiants
pubmed: 32075831
pii: bmjopen-2019-033584
doi: 10.1136/bmjopen-2019-033584
pmc: PMC7045090
doi:
Banques de données
NTR
['NTR28773']
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e033584Investigateurs
J W Elshof
(JW)
Bhp Elsman
(B)
J F Hamming
(JF)
J A van Herwaarden
(JA)
Rhj Kropman
(R)
M M Lensvelt
(MM)
P P Poyck
(PP)
Gwh Schurink
(G)
Aaea de Smet
(A)
S M van Sterkenburg
(SM)
C Ünlü
(C)
A C Vahl
(AC)
Hjm Verhagen
(H)
Pwhe Vriens
(P)
Jppm de Vries
(J)
J J Wever
(JJ)
W Wisselink
(W)
C J Zeebregts
(CJ)
Informations de copyright
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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