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Tongue Reconstruction with Innervated Thigh Muscle

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000173998
Acronym
TRIVALT
Enrollment
10
Registered
2020-02-17
Start date
2020-03-01
Completion date
2023-12-31
Last updated
2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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

Sponsors

Chris O Brien Lifehouse Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026