ANZCTR - Registration

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. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
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

ACTRN12620000173998p

Ethics application status

Submitted, not yet approved

Date submitted

10/11/2019

Date registered

17/02/2020

Date last updated

17/02/2020

Date data sharing statement initially provided

17/02/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Tongue Reconstruction with Innervated Thigh Muscle

Scientific title

Tongue Reconstruction with Innervated Vastus Lateralis and Antero-Lateral Thigh Free Flap

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

N/A

Trial acronym

TRIVALT

Linked study record

N/A

Health condition

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

Tongue cancer

Condition category

Condition code

Cancer

Head and neck

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Reconstruction of defect following resection of tongue for malignancy with innervated vastus laterals and anterolateral thigh flap. The steps of this surgery are harvesting of the soft tissue flap and muscle with the innervation intact from the thigh, as routinely done for microvascular reconstruction of he tongue. Microvascular anastomosis will performed as per standard technique with 8-0 nylon. Surgery will be performed by Jonathan Clark/James Wykes. The duration of surgery will be on average 8-10 hours

Intervention code [1]

Treatment: Surgery

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Assessment of the impact of innervated free flap reconstruction of large tongue defects after subtotal/total glossectomy on swallowing function (composite outcome) The swallowing assessment is through videofluouroscopy, and functional endoscopic evaluation of swallowing The speech assessment is through speech and intelligibility assessment (sentences from Frenchay Articulation Assessment, Rainbow Passage and Conversational Speech), intelligibility and percentage of consonants correct and subjective intelligibility by listeners blinded to patient characteristics, and speech handicap index (SHI)

Timepoint [1]

12 months after surgery

Secondary outcome [1]

Assessment of the impact of innervated free flap reconstruction of large tongue defects after subtotal/total glossectomy on speech function (composite outcome) The swallowing assessment is through videofluouroscopy, and functional endoscopic evaluation of swallowing The speech assessment is through speech and intelligibility assessment (sentences from Frenchay Articulation Assessment, Rainbow Passage and Conversational Speech), intelligibility and percentage of consonants correct and subjective intelligibility by listeners blinded to patient characteristics, and speech handicap index (SHI)

Timepoint [1]

12 months after surgery

Secondary outcome [2]

- To assess the impact of the intervention on Quality of Life (QoL) using EORTC H&N 35 questionnaire

Timepoint [2]

12 months after surgery

Secondary outcome [3]

- To assess the impact of the intervention on tongue range of motion (using weighted scales 0-5 of each individual action, such as elevation, depression, right deviation, left deviation, protrusion, retraction)

Timepoint [3]

12 months after surgery

Secondary outcome [4]

- To assess the impact of innervated free flap reconstruction of the tongue on long-term airway patency and protection from aspiration using videofluroscopy and FEES (this is a composite score)

Timepoint [4]

12 months after surgery

Eligibility

Key inclusion criteria

Tongue cancer requiring resection of >1/2 of the tongue

Minimum age

18 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- Preservation of the entire hypoglossal nerve on either side of the resection
- Contraindication for general anaesthesia
- Congenital or acquired neuro-degenerative disorder
- Inability to understand the study requirements or rehabilitation

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Not applicable

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Not applicable

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Descriptive statistics of analysis of speech, swallowing and sensorimotor function of tongue

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/03/2020

Actual

Date of last participant enrolment

Anticipated

31/12/2023

Actual

Date of last data collection

Anticipated

31/12/2024

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

The Chris O’Brien Lifehouse - Camperdown

Recruitment hospital [2]

Wollongong Hospital - Wollongong

Recruitment postcode(s) [1]

2050 - Camperdown

Recruitment postcode(s) [2]

2500 - Wollongong

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Chris O'Brien Lifehouse Hospital

Address [1]

119-143 Missenden Road, Camperdown NSW 2050

Country [1]

Australia

Primary sponsor type

Hospital

Name

Chris O Brien Lifehouse Hospital

Address

119-143 Missenden Road, Camperdown NSW 2050

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Sydney Local Health District

Ethics committee address [1]

Level 11, KGV Building Missenden Road 
CAMPERDOWN NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/09/2019

Approval date [1]

Ethics approval number [1]

2019/ETH12967

Summary

Brief summary

The purpose of this study is to trial a new method for rebuilding the tongue after cancer surgery

Who is it for?
You may be eligible for this study if you are aged 18 or over and have tongue cancer which requires at least half the tongue to be removed.

Study details
All participants in the study will undergo a reconstructive surgery where a piece of thigh muscle will be used to rebuild part of the tongue. This procedure takes place general anaesthesia during the same surgical procedure where the excision of the tongue cancer takes place, and the entire proceduretakes approximately 8-10 hours. As part of the study, all participants will have post-op assessments of tongue function and answer some questionnaires.

It is hoped this study will help us better understand and standardize tongue reconstruction to improve speech and swallowing outcomes.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr James Wykes

Address

VWO, Department of Surgery, Wollongong Public Hospital, Loftus St, Wollongong NSW 2500, Australia

Country

Australia

Phone

+61 410594383

Fax

[email protected]

Contact person for public queries

Name

James Wykes

Address

VWO, Department of Surgery, Wollongong Public Hospital, Loftus St, Wollongong NSW 2500, Australia

Country

Australia

Phone

+61 410594383

Fax

[email protected]

Contact person for scientific queries

Name

James Wykes

Address

VWO, Department of Surgery, Wollongong Public Hospital, Loftus St, Wollongong NSW 2500, Australia

Country

Australia

Phone

+61 410594383

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No IPD sharing reason/comment: For confidentiality reasons we do not plan to share IPD

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
5602	Study protocol					Study-related document.doc

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically