ANZCTR - Registration

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.

Reset your password and enable multi-factor authentication (MFA)

For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.

Go to the Login page, click ‘reset password’ and follow the instructions.
Check your email for the link to set a new password.
Create a new password that meets requirements.
Return to the Login page and enter your new password. A verification code will be sent to your email.
Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12618000356268

Ethics application status

Approved

Date submitted

12/01/2018

Date registered

9/03/2018

Date last updated

28/04/2021

Date data sharing statement initially provided

27/02/2020

Date results provided

28/04/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Modelling risk of early post-operative complications for patients undergoing major lower limb amputation

Scientific title

Modelling risk of in-hospital mortality and other early post-operative complications for patients undergoing major lower limb amputation entered into the United Kingdom National Vascular Registry

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1207-3753

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Lower limb amputation

Condition category

Condition code

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Musculoskeletal

Other muscular and skeletal disorders

Surgery

Other surgery

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

Target follow-up type

Days

Description of intervention(s) / exposure

Patients undergoing major lower limb amputation who are entered into the United Kingdom National Vascular Registry
Duration of observation: from time of surgery until discharge from hospital.

Intervention code [1]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

In-hospital mortality, as entered into the registry by the hospital or unit responsible for the patient's care, and validated by the surgeon responsible for the patient's care.

Timepoint [1]

The registry collects this outcome prospectively from the hospital or unit responsible for the patient's care and this is validated by the surgeon responsible for the patient's care. We will assess this retrospectively from the registry at the date of study commencement.

Secondary outcome [1]

Length of post-operative stay in hospital, as entered into the registry by the hospital or unit responsible for the patient's care, and validated by the surgeon responsible for the patient's care.

Timepoint [1]

Secondary outcome [2]

Return to theatre during primary admission, as entered into the registry by the hospital or unit responsible for the patient's care, and validated by the surgeon responsible for the patient's care.

Timepoint [2]

Secondary outcome [3]

Re-admission to a higher level of care during primary admission, as entered into the registry by the hospital or unit responsible for the patient's care, and validated by the surgeon responsible for the patient's care.

Timepoint [3]

Secondary outcome [4]

Post-operative complications during primary admission, as entered into the registry by the hospital or unit responsible for the patient's care, and validated by the surgeon responsible for the patient's care.

Timepoint [4]

Eligibility

Key inclusion criteria

Patients undergoing major lower limb amputation entered into the United Kingdom National Vascular Registry between January 1st 2014 and December 31st 2016

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients not entered into the database, or not undergoing major lower limb amputation during the study period.

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Retrospective

Statistical methods / analysis

Logistic regression analysis will be used to develop models for the outcomes using pre-operative and peri-operative predictors. Information Criterion analysis will be used to select predictors in order to generate a parsimonious model which avoids over-fitting. Bootstrap methodology will then be used to assess performance of the model, and compare this to existing risk prediction models, as well as comparing the results obtained using complete case analysis with those obtained using multiple imputation, to assess the impact of the method of handling missing data on the results. Missing data will be handled using both complete case analysis and multiple imputation with chained equations.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

30/03/2018

Actual

30/03/2018

Date of last participant enrolment

Anticipated

30/05/2018

Actual

30/05/2018

Date of last data collection

Anticipated

30/06/2018

Actual

30/06/2018

Sample size

Target

8000

Accrual to date

Final

9549

Recruitment outside Australia

Country [1]

United Kingdom

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Aneurin Bevan University Health Board

Address [1]

Clinical Research and Innovation Centre St Woolos Hospital Block C Stow Hill Newport, South Wales NP20 4SZ

Country [1]

United Kingdom

Primary sponsor type

Government body

Name

Aneurin Bevan University Health Board

Address

Clinical Research and Innovation Centre
St Woolos Hospital
Block C
Stow Hill
Newport, South Wales
NP20 4SZ

Country

United Kingdom

Secondary sponsor category [1]

Individual

Name [1]

Christopher P Twine

Address [1]

Vascular Institute Royal Gwent Hospital Cardi Road Newport NP20 2UB

Country [1]

United Kingdom

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Wales REC 3

Ethics committee address [1]

Health and Care Research Wales Support Centre
Castlebridge 4
15-19 Cowbridge Road East
Cardiff CF11 9AB

Ethics committee country [1]

United Kingdom

Date submitted for ethics approval [1]

17/01/2018

Approval date [1]

29/01/2018

Ethics approval number [1]

16/WA/0353

Summary

Brief summary

The appropriate counselling of patients about peri- and post-operative risks is an essential part of the process of consent to surgery. Patients undergoing major lower limb amputation (MLLA) are a high risk group, with 30-day mortality rates of around 10%, making MLLA the highest risk common Vascular Surgery operation other than ruptured abdominal aortic aneurysm (AAA) repair: higher than elective open AAA repair (3.0%) or lower limb bypass (3.0%).  Recent UK court rulings about patient consent have brought this issue to the fore for both patients and surgeons alike.  This is an evolving area, but current advice is now that ‘surgeons are required to engage in a consenting process tailored to the individual patient with detailed, accurate and realistic explanations of the pros and cons of surgery.’  In procedures such as MLLA, where individual risk clearly varies widely between patients, it is important therefore to be able to quantify risks as accurately as possible.  The issue of risk prediction for high-risk surgical procedures is also important in light of the advent of surgeon-specific outcome publication in the United Kingdom.  In order to reduce the likelihood that high risk patients are denied procedures which they might otherwise have chosen to undergo as a result of a surgeon’s unwillingness to run the risk of poor outcomes publication, it is essential to be able to appropriately risk adjust these national audits.
Using existing, prospectively collected data from the United Kingdom National Vascular Registry, we will develop models to predict the chances of complications after surgery including death in hospital, prolonged stay in hospital, need to go back to the operating theatre for another operation, post-operative chest infection and post-operative heart problems.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Christopher P Twine

Address

Vascular Institute Royal Gwent Hospital Cardiff Road Newport NP20 2UB

Country

United Kingdom

Phone

+44 1633 234124

Fax

[email protected]

Contact person for public queries

Name

Graeme Ambler

Address

Division of Population Medicine Cardiff University School of Medicine 3rd Floor Neuadd Meirionnydd Heath Park Cardiff CF14 4YS

Country

United Kingdom

Phone

+44 1633 234124

Fax

[email protected]

Contact person for scientific queries

Name

Graeme Ambler

Address

Division of Population Medicine Cardiff University School of Medicine 3rd Floor Neuadd Meirionnydd Heath Park Cardiff CF14 4YS

Country

United Kingdom

Phone

+44 1633 234124

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• All data is available upon request to anyone who wishes to access it from the UK National Vascular Registry, following approval of the data controlling committee

Conditions for requesting access:
• -

What individual participant data might be shared?

• All data is available upon request from the UK National Vascular Registry, following approval of the data controlling committee

What types of analyses could be done with individual participant data?

• All data is available upon request from the UK National Vascular Registry, following approval of the data controlling committee, in order to achieve the aims in an approved proposal.

When can requests for individual participant data be made (start and end dates)?

From:
Data is available currently upon request from the UK National Vascular Registry, following approval of the data controlling committee.
Start date: 30/06/2018
End date: No end date determined

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• All data is available upon request from the UK National Vascular Registry, following approval of the data controlling committee. This can be done using the 'contact-us' form on the UK National Vascular Registry Website: https://www.vsqip.org.uk/contact-us/

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Prognostic Risk Modelling for Patients Undergoing Major Lower Limb Amputation: An Analysis of the UK National Vascular Registry.	2020	https://dx.doi.org/10.1016/j.ejvs.2019.12.006

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically