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Frailty in Vascular Patients Undergoing Surgery

Vascular Frailty - An Observational Cohort Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03668821
Enrollment
300
Registered
2018-09-13
Start date
2021-01-01
Completion date
2025-10-01
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysmal Disease, Carotid Artery Diseases, Peripheral Artery Disease, Vascular Diseases

Keywords

Vascular Diseases, Peripheral Artery Disease

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.

Interventions

OTHERQuestionnaire

Quality of life and frailty questionnaires

Sponsors

Imperial College Healthcare NHS Trust
CollaboratorOTHER
Imperial College London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between electronic Frailty Index and survival and complication rate.6 monthsSurvival and rate of complication correlated with the pre-operative frailty score (electronic Frailty Index).
Correlation between Q Mortality Index and survival and complication rate.6 monthsSurvival and rate of complication correlated with the pre-operative frailty score (Q Mortality Index).
Correlation between ACS Risk Calculator Score and survival and complication rate.6 monthsSurvival and rate of complication correlated with the pre-operative frailty score (ACS Risk Calculator).
Correlation between V-Possum and survival and complication rate.6 monthsSurvival and rate of complication correlated with the pre-operative frailty score (V-Possum).

Secondary

MeasureTime frameDescription
Activity Levels Pre and Post Surgery as measured by the General Practice Physical Activity Questionnaire6 monthsGeneral Practice Physical Activity Questionnaire will be used to assess patient reported activity before and after surgery.
Quality of Life Pre and Post Surgery as measure by the EuroQoL EQ-5D questionnaire6 monthsEuroQol EQ-5D Quality of Life questionnaire will be used to assess patient reported quality of life before and after surgery.

Countries

United Kingdom

Contacts

Primary ContactTristan R Lane, PhD FRCS
tristan.lane@imperial.ac.uk02033117317

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026