1. To determine the influence of frailty on predicting an increase in HRQL in elderly peripheral vascular surgery patients. 2. To develop an 'AGE-VASC score' for predicting an increase in HRQL after cardiac surgery based on surgical risk…
ID
Source
Brief title
Condition
- Age related factors
- Vascular therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpunt is an increase >10 points of the physical or mental component
score of the SF-12 health status 12 months after cardiac surgery.
Secondary outcome
Secundary endpoints are the incidence of postoperative complications, length of
ICU and hospital stay, HRQL at 3 months, psychosocially and physical
functioning (WHODAS) and impairment in walking (Walking Impairment
Questionnaire WIQ (WIQ)) at 3 and 12 months.
Background summary
In elderly patients peripheral arterial surgery is associated with risk of
postoperative morbidity, mortality, loss of self-reliance and decreased health
related quality of life (HRQL). Such risk is further increased in frail
patients. Frailty results in loss of functional capacity and is characterised
by weight loss, sarcopenia and decreases physical activity. The influence of
frailty on postoperative outcome after peripheral vascular surgery is not
implemented in current international risk prediction models.
Study objective
1. To determine the influence of frailty on predicting an increase in HRQL in
elderly peripheral vascular surgery patients.
2. To develop an 'AGE-VASC score' for predicting an increase in HRQL after
cardiac surgery based on surgical risk factors, comorbidities and frailty.
Study design
Prospective, observational, cohort study. Patients are followed up for 1 year.
Primary endpoint is an increase in HRQL.
Study burden and risks
Since this is an observational study, there is no associated risk for the
patient. It takes 30 minutes to perform the additional questionnaire, 3
physical tests and 1 AGE reader test. Blood sampling will take place at 1 time
point. One sample will be taken at start of surgery. It takes 10 minutes to
complete the SF-12 health status questionnaire, WHODAS 2.0 questionnaire and
WIQ at 3 and 12 months after surgery. Study patients undergo regular anesthesia
screening prior to surgery at the outpatient anesthesia clinic, similar to
patients not included in the study. The results of the additional questionnaire
and tests hold no consequences for whether or not the patient proceeds to
surgery. After visiting the outpatient clinic a study patient receives regular
preoperative cardiac care, similar to patients not included in the study.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
• >=70 jaar
• mentally competent
• Elective surgical intervention for peripheral arterial disease
• Signed informed consent
Exclusion criteria
Not applicable
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 | NL55038.100.15 |