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AGE-VASC: Anesthesia Geriatric Evaluation and Quality of Life After Peripheral Vascular Surgery

Sponsor
St. Antonius Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT02820831
Collaborator
(none)
88
Enrollment
1
Location
55.8
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A prospective observational cohort study to assess the predictive value of preoperative frailty on postoperative quality of life in peripheral vascular surgery patients.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    88 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Anesthesia Geriatric Evaluation and the Prediction of Quality of Life in Elderly Peripheral Vascular Surgery Patients
    Actual Study Start Date :
    Jun 9, 2016
    Actual Primary Completion Date :
    Feb 2, 2021
    Actual Study Completion Date :
    Feb 2, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Quality of Life [12 months after surgery]

      Assessed by Medical Outcomes Study Short Form-36 (SF-36)

    Secondary Outcome Measures

    1. Quality of Life [3 months after surgery]

      Assessed by Medical Outcomes Study Short Form-36 (SF-36)

    2. Walking Impairment [3 and 12 months after surgery]

      Assessed by Walking Impairment Questionnaire

    3. Psychosocial or physical functioning [3 and 12 months after surgery]

      Assessed by World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)

    4. Incidence of postoperative complications and mortality [30 days after surgery]

      Postoperative complications scored are mortality, rebleed, infection, hematoma, respiratory insufficiency, cerebrovascular accident, renal failure.

    5. Length of in-hospital stay [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    70 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St Antonius hospital Nieuwegein Utrecht Netherlands 3435 CM

    Sponsors and Collaborators

    • St. Antonius Hospital

    Investigators

    • Principal Investigator: Peter G Noordzij, MD, PhD, St. Antonius Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    dr. P. Noordzij, dr. P.G. Noordzij, St. Antonius Hospital
    ClinicalTrials.gov Identifier:
    NCT02820831
    Other Study ID Numbers:
    • NL 55038.100.15
    First Posted:
    Jul 1, 2016
    Last Update Posted:
    Oct 8, 2021
    Last Verified:
    Sep 1, 2021
    Keywords provided by dr. P. Noordzij, dr. P.G. Noordzij, St. Antonius Hospital
    Frail Elderly
    Peripheral Vascular Surgery
    Risk Assessment
    Functional status

    Study Results

    No Results Posted as of Oct 8, 2021