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Quality of LifeAGE-VASCNCT02820831

Anesthesia Geriatric Evaluation and Quality of Life After Peripheral Vascular Surgery

An observational study of Quality of Life, run by St. Antonius Hospital at 1 site in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 70 years and older
Conditions the study is for
Quality of Life
How many people
88 participants
Where
1 siteNetherlands
Study dates
9 Jun 2016to 2 Feb 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Patients planned for elective vascular surgery of the lower limb or amputation including surgical procedured combined with endovascular.

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site
  • St Antonius hospital

    Nieuwegein, Utrecht, 3435 CM

Other trials in Netherlands

About this study

Official title: Anesthesia Geriatric Evaluation and the Prediction of Quality of Life in Elderly Peripheral Vascular Surgery Patients

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

Read the 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.

Conditions
Quality of Life
Keywords
Frail Elderly, Peripheral Vascular Surgery, Risk Assessment, Functional status

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of Life

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

    Measured: 12 months after surgery

Secondary outcomes (5)
  1. Quality of Life

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

    Measured: 3 months after surgery

  2. Walking Impairment

    Assessed by Walking Impairment Questionnaire

    Measured: 3 and 12 months after surgery

  3. Psychosocial or physical functioning

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

    Measured: 3 and 12 months after surgery

  4. Incidence of postoperative complications and mortality

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

    Measured: 30 days after surgery

  5. Length of in-hospital stay

    Length of stay will be measured from date of surgery to date of discharge

    Measured: Post-surgical. The expected length of stay is 5-7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2016 (estimated)
  2. Study start9 Jun 2016
  3. Primary completion2 Feb 2021
  4. Study completion2 Feb 2021

Why it stopped: Slow inclusion

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02820831
Sponsor's protocol ID
NL 55038.100.15
Acronym
AGE-VASC
Status last verified
Sep 2021
First submitted
29 Jun 2016
Last updated
8 Oct 2021
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Quality of Life, run by St. Antonius Hospital at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Slow inclusion). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.

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