Frailty in Vascular Patients Undergoing Surgery

NCT ID: NCT03668821

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2025-10-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Vascular Diseases Carotid Artery Diseases Aneurysmal Disease Peripheral Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Carotid Artery Disease

Patients with Carotid Artery Disease. Quality of life and frailty questionnaires

Questionnaire

Intervention Type OTHER

Quality of life and frailty questionnaires

Aneurysmal Disease

Patients with Aneurysmal Disease. Quality of life and frailty questionnaires

Questionnaire

Intervention Type OTHER

Quality of life and frailty questionnaires

Peripheral Artery Disease

Patients with Peripheral Artery Disease. Quality of life and frailty questionnaires

Questionnaire

Intervention Type OTHER

Quality of life and frailty questionnaires

Interventions

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Questionnaire

Quality of life and frailty questionnaires

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College Healthcare NHS Trust

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alun H Davies, DM FRCS

Role: STUDY_CHAIR

Imperial College London

Locations

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Imperial College London

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Tristan R Lane, PhD FRCS

Role: CONTACT

02033117317

Facility Contacts

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Tristan R Lane, PhD FRCS

Role: primary

Majd Rawashdeh

Role: primary

Other Identifiers

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18HH4445

Identifier Type: -

Identifier Source: org_study_id

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