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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] 299725 0
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 315072 0
Condition category
Condition code
Cancer 313408 313408 0 0
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] 315990 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321887 0
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] 321887 0
12 months after surgery
Secondary outcome [1] 376597 0
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] 376597 0
12 months after surgery
Secondary outcome [2] 377848 0
- To assess the impact of the intervention on Quality of Life (QoL) using EORTC H&N 35 questionnaire
Timepoint [2] 377848 0
12 months after surgery
Secondary outcome [3] 377849 0
- 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] 377849 0
12 months after surgery
Secondary outcome [4] 377850 0
- 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] 377850 0
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?
No
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
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15106 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [2] 15107 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 28401 0
2050 - Camperdown
Recruitment postcode(s) [2] 28402 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 304196 0
Hospital
Name [1] 304196 0
Chris O'Brien Lifehouse Hospital
Country [1] 304196 0
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] 304772 0
None
Name [1] 304772 0
Address [1] 304772 0
Country [1] 304772 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304665 0
Sydney Local Health District
Ethics committee address [1] 304665 0
Level 11, KGV Building Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 304665 0
Australia
Date submitted for ethics approval [1] 304665 0
30/09/2019
Approval date [1] 304665 0
Ethics approval number [1] 304665 0
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 97778 0
Dr James Wykes
Address 97778 0
VWO, Department of Surgery,
Wollongong Public Hospital,
Loftus St, Wollongong NSW 2500, Australia
Country 97778 0
Australia
Phone 97778 0
+61 410594383
Fax 97778 0
Email 97778 0
[email protected]
Contact person for public queries
Name 97779 0
James Wykes
Address 97779 0
VWO, Department of Surgery,
Wollongong Public Hospital,
Loftus St, Wollongong NSW 2500, Australia
Country 97779 0
Australia
Phone 97779 0
+61 410594383
Fax 97779 0
Email 97779 0
[email protected]
Contact person for scientific queries
Name 97780 0
James Wykes
Address 97780 0
VWO, Department of Surgery,
Wollongong Public Hospital,
Loftus St, Wollongong NSW 2500, Australia
Country 97780 0
Australia
Phone 97780 0
+61 410594383
Fax 97780 0
Email 97780 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
For confidentiality reasons we do not plan to share IPD


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5602Study protocol    378680-(Uploaded-10-11-2019-12-59-53)-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.