No registrations found.
ID
Source
Brief title
Health condition
Abdominal Aortic Aneurysm, Endovascular aortic repair, Standardised imaging surveillance, Test Anxiety Scale, Surveys and Questionnaires
Sponsors and support
Intervention
Outcome measures
Primary outcome
To detect differences in anxiety levels directly after imaging surveillance and before obtaining the imaging result compared to baseline anxiety levels.
Secondary outcome
- differences in global and physical health directly after imaging surveillance and before obtaining the imaging result compared to baseline anxiety levels.
- the necessity of standardised surveillance according to patients
Background summary
Rationale: Evidence suggests that standardised imaging surveillance may not be beneficial to all patients after endovascular aortic repair (EVAR). Therefore, when weighing the benefits and harms of yearly standardised imaging surveillance after endovascular aortic repair (EVAR), it is important to include the patients’ perspective.
Objective: Defining the negative or positive impact of standardised imaging surveillance in EVAR-patients.
Study design: a multicentre prospective cohort study in 4 medical centres.
Study population: All adult patients, with an infrarenal asymptomatic abdominal aneurysm (AAA) visiting the outpatient clinic of a participating vascular surgery department or vascular medical centre for EVAR follow-up.
Intervention (if applicable): Our study does not entail a (new) medicinal or surgical intervention. Patients will be asked to fill out standardized questionnaires after follow-up imaging and in between two follow-up visits.
Main study parameters/endpoints: The level of anxiety at different times during follow-up.
Study objective
We hypothesize that anxiety symptoms worsen after follow-up imaging compared to patients baseline anxiety levels.
Study design
All adult patients, with an infrarenal asymptomatic abdominal aneurysm (AAA) visiting the outpatient clinic of a participating vascular surgery department for EVAR follow-up
Intervention
Our study does not entail a (new) medicinal or surgical intervention. Patients will be asked to fill out standardised questionnaires.
Department of Vascular Surgery G4-111.1,
P.O. Box 22660
R. Balm
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5667832
r.balm@amc.nl
Department of Vascular Surgery G4-111.1,
P.O. Box 22660
R. Balm
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5667832
r.balm@amc.nl
Inclusion criteria
- Age above 17 year
- Patients with an asymptomatic infrarenal abdominal aortic aneurysm
- Patient with imaging after EVAR
Exclusion criteria
- Insufficient understanding of the Dutch language or cognitively unable to complete Dutch questionnaires
- Life expectancy less than 1 year
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7214 |
| NTR-old | NTR7413 |
| Other | 843004119 ZonMw : W18_226 #18.270 MEC AMC |