Clinical trial NCT03668821: Frailty in Vascular Patients Undergoing Surgery
Official title: Vascular Frailty - An Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vascular Diseases
Carotid Artery Diseases
Aneurysmal Disease
Peripheral Artery Disease
Keywords: Vascular Diseases
Peripheral Artery Disease
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Imperial College Healthcare NHS Trust
First posted: 2018-09-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients attending Vascular Surgery department for aortic aneurysm repair, carotid artery surgery and lower limb revascularisation.

Brief summary: An observational cohort study of the frailty of vascular surgery patients undergoing intervention and their outcomes.

Detailed description: Vascular surgical operations are major procedures with significant associated morbidity and mortality. Frailty is a major factor influencing surgical outcome, but the effect on morbidity/mortality and quality of life is poorly understood in vascular surgery. Activity levels play a significant role in frailty and in pre-intervention preparation. It is anticipated that as frailty levels increase, activity levels decrease. It is hypothesised that vascular surgery patients suffer from a high prevalence of frailty and that increasing frailty will lead to increased morbidity and mortality and decreased quality of life.

This initial study will provide the foundations to identify targets for improvement in degree of frailty, appropriateness for surgery and outcome.

This project aims to:

Assess and quantify the prevalence of frailty as well as recording activity levels in the vascular surgery patient cohort Explore the impact of frailty and pre-op activity on surgical outcomes in the vascular surgical patient cohort to guide surgical treatments as well as future studies aimed at improving frailty and activity and thereby quality of life.

Identification of an appropriate metric of frailty for this population group to include activity, is a secondary aim of this proposal.

Eligibility criteria: Inclusion Criteria:

1. All patients attending for aortic aneurysm repair, carotid artery surgery and lower limb revascularisation under the care of the Vascular Surgery team
2. Willing and able to give informed written consent

Exclusion Criteria:

1. Those unable to give informed written consent
2. Those \<18 years of age
3. In the opinion of the investigator unable or unwilling to comply with the requirements of the study

Primary outcomes:
measure: Correlation between electronic Frailty Index and survival and complication rate.
timeFrame: 6 months
measure: Correlation between Q Mortality Index and survival and complication rate.
timeFrame: 6 months
measure: Correlation between ACS Risk Calculator Score and survival and complication rate.
timeFrame: 6 months
measure: Correlation between V-Possum and survival and complication rate.
timeFrame: 6 months
Secondary outcomes:
measure: Activity Levels Pre and Post Surgery as measured by the General Practice Physical Activity Questionnaire
timeFrame: 6 months
measure: Quality of Life Pre and Post Surgery as measure by the EuroQoL EQ-5D questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College London
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Alun H Davies, DM FRCS
role: STUDY_CHAIR
References: