Primary research question:To evaluate the impact of open versus endovascular invasive treatment in different types of surgery (AAA, CEA, LLR) on health status. Secondary research questions:To examine the prognostic impact of quality of life in PAD…
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is health status. Health status will be measured by
the translated Dutch version of the PAQ, an disease-specific instrument for
assessing health status in patients with PAD, and the Dutch version of the
EQ-5D, a standardized, generic instrument for describing and valuing health.
Secondary outcome
Delirium (scores on the Delirium Scale > 12); mortality (both cardiac and
non-cardiac); morbidity (i.e. a composite of rehospitalisation due to failed
grafts). Data for these endpoints will be retrieved from the patients' medical
records and assessed 2 years after surgery, including also the date of the
event.
Background summary
Peripheral arterial disease (PAD) is a common chronic condition and is
associated with increased cardiovascular morbidity and mortality. The
management of patients with PAD has changed in the last decades with the
introduction of endovascular techniques and other treatment modalities.
Traditionally, the success of interventions is measured with clinical measures,
such as the ankle-brachial index, patency rates, and survival rates. Relying
solely upon these techniques, however, fails to ascertain whether the
intervention has a beneficial impact on the patient*s ability to function in
daily life.
The impact of surgical and endovascular interventions on costs, quality of
life, and functional status is not systematically evaluated yet. Preliminary
evidence in abdominal aortic aneurysm patients indicates that the perioperative
advantages regarding survival and quality of life is not sustained after the
first postoperative year. The adoption of sensitive patient-centered outcome
measures is increasing in order to quantify the benefits of different treatment
strategies and their cost-effectiveness. In addition to using health status
measures as outcome measures, health status measurements may provide prognostic
information to guide clinical decision-making. Health status measurements can
therefore potentially be used in clinical practice to identify patients who are
at relatively high risk for adverse health outcomes and may benefit from more
intensive follow-up and more aggressive treatment, including pharmacological,
invasive and/ or behavioural interventions.
Study objective
Primary research question:
To evaluate the impact of open versus endovascular invasive treatment in
different types of surgery (AAA, CEA, LLR) on health status.
Secondary research questions:
To examine the prognostic impact of quality of life in PAD:
a. Short-term prognosis: perioperative complications (e.g. delirium) and
graft-patency rates
b. Long-term prognosis: cardiovascular events and mortality
Study design
The current study is a prospective, observational, single-centre study, with a
12-month follow-up. Psychological assessments will take place at 5 time points:
T0=pre-operative (i.e., at the anesthesiology department, pre-operative
screening), T1=in-hospital delirium assessment, T2=30 days, T3=6 months, T4=12
months. Clinical assessments coincide with the T0 and T1 assessments. It should
be noted that none of these parameters are assessed specially for the study,
but comprise clinical parameters that are assessed standardly in patients
undergoing vascular surgery. During follow-up, survival data for all patients
will be obtained from municipal civil registries. A questionnaire is
subsequently sent to all living patients together with specific inquiries on
repeat hospital admissions and major cardiac events. All questionnaires are
standardized and validated. Patients will be approached by the physician for
study participation. They will be informed about the study both orally and in
writing and be asked to sign an informed consent form.
Study burden and risks
Psychological assessments take place at 5 time moments. The patients will be
sent questionnaires, except for T0 and T1, to his or her home address and will
be able to complete and return the questionnaires at a suitable time. The
maximal time needing to complete the questionnairesis is 30 minutes.
's Gravendijkwal 230
3015 CE
NL
's Gravendijkwal 230
3015 CE
NL
Listed location countries
Age
Inclusion criteria
-Patient scheduled for non-cardiac vascular surgery
-Patient older than 18 years
-Patient have signed informed consent
Exclusion criteria
-A life expectancy less than 12 months
-Presence of severe psychopathological comorbidities (e.g., psychosis, suicidal ideation)
-Severe cognitive impairment (Mini Mental Status Examination Score of 23 or lower) --Insufficient knowledge of the Dutch language.
Design
Recruitment
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 |
---|---|
CCMO | NL24093.078.08 |