Anesthesia Geriatric Evaluation and Quality of Life After Peripheral Vascular Surgery

Quality of Life Clinical Trial

— AGE-VASC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02820831
• Other study ID #: NL 55038.100.15
• Status: Terminated
• Start date: June 9, 2016
• Est. completion date: February 2, 2021

Study information

• Verified date: September 2021
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 88
• Est. completion date: February 2, 2021
• Est. primary completion date: February 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Quality of Life

Locations

Country	Name	City	State
Netherlands	St Antonius hospital	Nieuwegein	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life	Assessed by Medical Outcomes Study Short Form-36 (SF-36)	12 months after surgery
Secondary	Quality of Life	Assessed by Medical Outcomes Study Short Form-36 (SF-36)	3 months after surgery
Secondary	Walking Impairment	Assessed by Walking Impairment Questionnaire	3 and 12 months after surgery
Secondary	Psychosocial or physical functioning	Assessed by World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)	3 and 12 months after surgery
Secondary	Incidence of postoperative complications and mortality	Postoperative complications scored are mortality, rebleed, infection, hematoma, respiratory insufficiency, cerebrovascular accident, renal failure.	30 days after surgery
Secondary	Length of in-hospital stay	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