- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02820831
Anesthesia Geriatric Evaluation and Quality of Life After Peripheral Vascular Surgery (AGE-VASC)
Anesthesia Geriatric Evaluation and the Prediction of Quality of Life in Elderly Peripheral Vascular Surgery Patients
Study Overview
Status
Conditions
Detailed Description
Introduction:
The percentage of elderly in the general population is increasing rapidly. Currently, the Dutch population comprises for one fifth of persons aged 65 years or older and recent estimates show this will increase to roughly a quarter in the next 20 years. Since th incidence of peripheral arterial disease increases with age, this rise in elderly will also reflect on the population of patients being referred for vascular surgery. Elderly patients are at higher risk for postoperative complications, mortality or functional decline than younger patients. In frail elderly this effect might be more pronounced. Frailty is an umbrella term that encompasses patient related factors such as weight loss, muscle wasting, inactivity, comorbidities and polypharmacy. Current scoring systems that are used to predict postoperative mortality and complications following vascular surgery perform poorly in the elderly population and do not take into account frailty. Moreover they are designed to predict mortality and complications and are not validated to predict patient reported outcome measures such as quality of life or functional status. The aim of the AGE VASC study is assess the value of frailty factors in predicting an improvement in quality of life one year after peripheral vascular surgery.
Methods:
The AGE VASC study is a prospective observational cohort study. All patients aged 70 years or older, scheduled for peripheral vascular surgery of the lower limb, mentally competent and have signed informed consent are eligible for the study. Before surgery patients will be screened for frailty using different questionnaires and physical tests. The battery of tests exists of Short Form 36 (SF36), Walking Impairment Questionnaire (WIQ), Multi Nutritional Assessment (MNA), Montreal Cognitive Assessment (MoCA), Nagi's scale for disability, Geriatric Depression Scale -8 (GDS8), three physical tests: five meter walking speed, timed get up and go test and hand grip strength. And a non-invasive measurement of Advanced Glycation Endproducts (AGEs). A blood sample will be taken to determine vitamin status, immune status and iron deficiency. After surgery, electronic patients charts will be studied to score postoperative complications or mortality. Three and twelve months after surgery patients will receive SF-36, WIQ, and World Health Organization Disability Assessment Schedule (WHODAS) 2.0 questionnaires to determine quality of life and functional status.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Utrecht
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Nieuwegein, Utrecht, Netherlands, 3435 CM
- St Antonius Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged 70 years or older
- Mentally competent
- Planned peripheral vascular surgery of the lower limb (femoral artery desobstruction, bypass surgery, amputation), possibly combined with endovascular procedure
- Signed informed consent
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life
Time Frame: 12 months after surgery
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Assessed by Medical Outcomes Study Short Form-36 (SF-36)
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12 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life
Time Frame: 3 months after surgery
|
Assessed by Medical Outcomes Study Short Form-36 (SF-36)
|
3 months after surgery
|
Walking Impairment
Time Frame: 3 and 12 months after surgery
|
Assessed by Walking Impairment Questionnaire
|
3 and 12 months after surgery
|
Psychosocial or physical functioning
Time Frame: 3 and 12 months after surgery
|
Assessed by World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)
|
3 and 12 months after surgery
|
Incidence of postoperative complications and mortality
Time Frame: 30 days after surgery
|
Postoperative complications scored are mortality, rebleed, infection, hematoma, respiratory insufficiency, cerebrovascular accident, renal failure.
|
30 days after surgery
|
Length of in-hospital stay
Time Frame: Post-surgical. The expected length of stay is 5-7 days
|
Length of stay will be measured from date of surgery to date of discharge
|
Post-surgical. The expected length of stay is 5-7 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Peter G Noordzij, MD, PhD, St. Antonius Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NL 55038.100.15
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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