NCT03403673

Brief Summary

Major vascular operations put the body under stress. We are trying to find out if the general health of a patient and the stress resulting from surgery can lead to the development of complications after surgery as well as increase the length of time spent in hospital. There is evidence to suggest that patients who are frail have a higher risk of developing complications after major surgery. Our aim is to ask you simple questions about your physical ability to perform daily life activities, assess your general health condition and ask you to do simple tasks such as drawing a clock or walking for a short distance to assess your speed of walking. Our main aim is to identify a tool that will assist us to identify patients who are at risk of frailty.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 26, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 19, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

January 19, 2018

Status Verified

December 1, 2017

Enrollment Period

1.2 years

First QC Date

January 11, 2018

Last Update Submit

January 11, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Clinical frailty scale validation in preoperative assessment of patients scheduled for vascular surgery

    Identify a tool that will assist us to identify patients who are at risk of frailty.

    June 2018

Interventions

There is evidence to suggest that patients who are frail have a higher risk of developing complications after major surgery. Our aim is to ask you simple questions about your physical ability to perform daily life activities, assess your general health condition and ask you to do simple tasks such as drawing a clock or walking for a short distance to assess your speed of walking. Our main aim is to identify a tool that will assist us to identify patients who are at risk of frailty

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All vascular patients attending the preoperative assessment clinics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Tees Hospitals NHS Foundation Trust

Middlesbrough, TS4 3BW, United Kingdom

RECRUITING

Related Publications (1)

  • Ayyash R, Knight J, Kothmann E, Eid M, Ayyash K, Colling K, Yates D, Mill A, Danjoux G. Utility and reliability of the Clinical Frailty Scale in patients scheduled for major vascular surgery: a prospective, observational, multicentre observer-blinded study. Perioper Med (Lond). 2022 Jan 31;11(1):6. doi: 10.1186/s13741-022-00240-9.

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 19, 2018

Study Start

April 26, 2017

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

January 19, 2018

Record last verified: 2017-12

Locations