Clinical Trials Directory

Trials / Terminated

TerminatedNCT02820831

Anesthesia Geriatric Evaluation and Quality of Life After Peripheral Vascular Surgery

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

Status
Terminated
Phase
Study type
Observational
Enrollment
88 (actual)
Sponsor
St. Antonius Hospital · Academic / Other
Sex
All
Age
70 Years
Healthy volunteers
Not accepted

Summary

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

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

Timeline

Start date
2016-06-09
Primary completion
2021-02-02
Completion
2021-02-02
First posted
2016-07-01
Last updated
2021-10-08

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT02820831. Inclusion in this directory is not an endorsement.