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Frailty in Vascular Patients Undergoing Surgery

Recruiting
Conditions
Peripheral Artery Disease
Vascular Diseases
Carotid Artery Diseases
Aneurysmal Disease
Interventions
Other: Questionnaire
Registration Number
NCT03668821
Lead Sponsor
Imperial College London
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
300
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
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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
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Carotid Artery DiseaseQuestionnairePatients with Carotid Artery Disease. Quality of life and frailty questionnaires
Aneurysmal DiseaseQuestionnairePatients with Aneurysmal Disease. Quality of life and frailty questionnaires
Peripheral Artery DiseaseQuestionnairePatients with Peripheral Artery Disease. Quality of life and frailty questionnaires
Primary Outcome Measures
NameTimeMethod
Correlation between Q Mortality Index and survival and complication rate.6 months

Survival 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 months

Survival and rate of complication correlated with the pre-operative frailty score (ACS Risk Calculator).

Correlation between electronic Frailty Index and survival and complication rate.6 months

Survival and rate of complication correlated with the pre-operative frailty score (electronic Frailty Index).

Correlation between V-Possum and survival and complication rate.6 months

Survival and rate of complication correlated with the pre-operative frailty score (V-Possum).

Secondary Outcome Measures
NameTimeMethod
Quality of Life Pre and Post Surgery as measure by the EuroQoL EQ-5D questionnaire6 months

EuroQol EQ-5D Quality of Life questionnaire will be used to assess patient reported quality of life before and after surgery.

Activity Levels Pre and Post Surgery as measured by the General Practice Physical Activity Questionnaire6 months

General Practice Physical Activity Questionnaire will be used to assess patient reported activity before and after surgery.

Trial Locations

Locations (2)

Imperial College Healthcare NHS Trust

🇬🇧

London, United Kingdom

Imperial College London

🇬🇧

London, United Kingdom

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