Benign Thyroid NoduleNCT06225765
A Prospective Trial Comparing Transoral Endoscopic Thyroidectomy Vestibular Approach (TOETVA) and Conventional Open Thyroidectomy
A study testing Transoral endoscopic thyroidectomy vestibular approach (TOETVA) and Traditional Open Thyroidectomy in people with Benign Thyroid Nodule and Suspicious Malignant Thyroid Nodule, run by Tseung Kwan O Hospital, Hong Kong at 1 site in Hong Kong.
Trial summary
To determine if transoral endoscopic thyroidectomy vestibular approach (TOETVA) is a safe and effective procedure compared to traditional open thyroidectomy. Surgical outcomes, patients' satisfaction, voice and swallowing outcomes will be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Thyroid Nodule, Suspicious Malignant Thyroid Nodule
- What is being tested?
- Transoral endoscopic thyroidectomy vestibular approach (TOETVA) and Traditional Open Thyroidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Benign thyroid nodule less than 4cm
- Suspicious malignant thyroid nodule less than 2cm, suitable for transoral endoscopic surgery
Who cannot join
- Patients under 18 years old
- Contraindication to general anaesthesia
- Vulnerable population (e.g. Cognitive impairment, pregnant)
- Previous anterior neck surgery
- Previous radiotherapy at the head and neck region
- Malignant thyroid nodule > 2cm
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- Presence of another malignancy, lateral neck, or distant metastasis
- Retrosternal goitre
- Cervical spine disease precluding extension of the neck
- Obesity with BMI > 35kg/m2
- Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
- Untreated active infection
- Non-correctable coagulopathy
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Otorhinolaryngology, Head and Neck Surgery, United Christian Hospital and Tseung Kwan O Hospital
Hong Kong
Zenon Yeung, MbChB, +852-39495442, dr.zenon.yeung@gmail.com
Thomas Hui, BSc, +852-39493549, hsc526@ha.org.hk
About this study
To determine if transoral endoscopic thyroidectomy vestibular approach (TOETVA) is a safe and effective procedure compared to traditional open thyroidectomy. Surgical outcomes, patients' satisfaction, voice and swallowing outcomes will be assessed.
Read the detailed description
This is a prospective case control study involving a total 40 patients, with 20 stratified into the test group receiving surgery under transoral endoscopic thyroidectomy vestibular approach (TOETVA) and 20 patients to the control group under traditional open approach. Subjects will be assigned to either group without randomization. Patients satisfactory score, voice and swallowing quality of life outcomes will be assessed using Voice Handicap Index (VHI) and MD Anderson Dysphagia Inventory (MDADI) outcomes. Surgical outcomes, for instance, lower lip numbness, skin injury, operative time, blood loss, vocal cord paralysis, temporary and permanent hypoparathyroidism will be assessed.
- Being tested
- Transoral endoscopic thyroidectomy vestibular approach (TOETVA), Traditional Open Thyroidectomy
- Keywords
- Thyroid nodule
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transoral endoscopic thyroidectomy vestibular approach (TOETVA)Procedure or surgery
Remote access thyroid surgery
Traditional Open ThyroidectomyProcedure or surgery
Open thyroidectomy via trans-cervical approach
| Study group | Role | What they receive |
|---|---|---|
| Transoral endoscopic thyroidectomy vestibular approach (TOETVA) | Experimental | Test group receiving surgery under transoral endoscopic thyroidectomy vestibular approach (TOETVA) Receives: Procedure: Transoral endoscopic thyroidectomy vestibular approach (TOETVA) |
| Traditional open surgery | Active comparator | Control group receiving traditional open thyroidectomy Receives: Procedure: Traditional Open Thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's satisfactory score
Visual analogue scale 0-10
Measured: Post-operative day 1
Patient's satisfactory score
Visual analogue scale 0-10
Measured: Post-operative 2 weeks
Patient's satisfactory score
Visual analogue scale 0-10
Measured: Post-operative 6 months
Post-operative pain
Visual analogue scale 0-10
Measured: Post-operative day 1
Post-operative pain
Visual analogue scale 0-10
Measured: Post-operative 2 weeks
Post-operative pain
Visual analogue scale 0-10
Measured: Post-operative 6 months
Voice quality of life
Voice Handicap Index - 30 assessing functional, physical and emotional scales
Measured: Post-operative day 1
Voice quality of life
Voice Handicap Index - 30 assessing functional, physical and emotional scales
Measured: Post-operative 2 weeks
Voice quality of life
Voice Handicap Index - 30 assessing functional, physical and emotional scales
Measured: Post-operative 6 months
Swallowing quality of life
MD Anderson dysphagia inventory (MDADI)
Measured: Post-operative day 1
Swallowing quality of life
MD Anderson dysphagia inventory (MDADI)
Measured: Post-operative 2 weeks
Swallowing quality of life
MD Anderson dysphagia inventory (MDADI)
Measured: Post-operative 6 months
Complication rate and types
Lower lip numbness, skin bruising or injury, wound infection, vocal cord paralysis, temporary hypoparathyroidism
Measured: Post-operative 2 weeks
Complication rate and types
Lower lip numbness, vocal cord paralysis, permanent hypoparathyroidism
Measured: Post-operative 6 months
Secondary outcomes (4)
Inpatient stay
Number of days of inpatient stay
Measured: An average of 0-2 days after the operation
Operative time
Minutes
Measured: Intra-operatively
Blood loss
Volume
Measured: Intra-operatively
Rate of conversion to open surgery
Percentage of conversion
Measured: Intra-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Jul 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Thyroid NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective case control study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tseung Kwan O Hospital, Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YEUNG WING CHI ZENON, Tseung Kwan O Hospital, Hong Kong
- Investigators
- Jason YK Chan, Study director, Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong KongZenon Yeung, Principal investigator, Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225765
- Sponsor's protocol ID
- KC/KE-23-0006/FR-4
- Status last verified
- Jul 2024
- First submitted
- 9 Jan 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial Comparing Transoral Endoscopic Thyroidectomy Vestibular Approach (TOETVA) and Conventional Open Thyroidectomy
- ClinicalTrials.gov ID
- NCT06225765
- Acronym / sponsor ID
- KC/KE-23-0006/FR-4
- Keywords
- Thyroid nodule
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tseung Kwan O Hospital, Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if transoral endoscopic thyroidectomy vestibular approach (TOETVA) is a safe and effective procedure compared to traditional open thyroidectomy. Surgical outcomes, patients' satisfaction, voice and swallowing outcomes will be assessed.
Detailed description
This is a prospective case control study involving a total 40 patients, with 20 stratified into the test group receiving surgery under transoral endoscopic thyroidectomy vestibular approach (TOETVA) and 20 patients to the control group under traditional open approach. Subjects will be assigned to either group without randomization. Patients satisfactory score, voice and swallowing quality of life outcomes will be assessed using Voice Handicap Index (VHI) and MD Anderson Dysphagia Inventory (MDADI) outcomes. Surgical outcomes, for instance, lower lip numbness, skin injury, operative time, blood loss, vocal cord paralysis, temporary and permanent hypoparathyroidism will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective case control study
| Arm | Type | Receives |
|---|---|---|
| Transoral endoscopic thyroidectomy vestibular approach (TOETVA) | Experimental | Procedure: Transoral endoscopic thyroidectomy vestibular approach (TOETVA)Test group receiving surgery under transoral endoscopic thyroidectomy vestibular approach (TOETVA) |
| Traditional open surgery | Active comparator | Procedure: Traditional Open ThyroidectomyControl group receiving traditional open thyroidectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Benign thyroid nodule less than 4cm
- Suspicious malignant thyroid nodule less than 2cm, suitable for transoral endoscopic surgery
Key exclusion criteria (14 listed)
- Patients under 18 years old
- Contraindication to general anaesthesia
- Vulnerable population (e.g. Cognitive impairment, pregnant)
- Previous anterior neck surgery
- Previous radiotherapy at the head and neck region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transoral endoscopic thyroidectomy vestibular approach (TOETVA)Remote access thyroid surgery | Procedure or surgery | Transoral endoscopic thyroidectomy vestibular approach (TOETVA) |
| Traditional Open ThyroidectomyOpen thyroidectomy via trans-cervical approach | Procedure or surgery | Traditional open surgery |
Primary outcome
Patient's satisfactory score
Time frame: Post-operative day 1
Visual analogue scale 0-10
Patient's satisfactory score
Time frame: Post-operative 2 weeks
Visual analogue scale 0-10
Patient's satisfactory score
Time frame: Post-operative 6 months
Visual analogue scale 0-10
Post-operative pain
Time frame: Post-operative day 1
Visual analogue scale 0-10
Post-operative pain
Time frame: Post-operative 2 weeks
Visual analogue scale 0-10
Post-operative pain
Time frame: Post-operative 6 months
Visual analogue scale 0-10
Voice quality of life
Time frame: Post-operative day 1
Voice Handicap Index - 30 assessing functional, physical and emotional scales
Voice quality of life
Time frame: Post-operative 2 weeks
Voice Handicap Index - 30 assessing functional, physical and emotional scales
Voice quality of life
Time frame: Post-operative 6 months
Voice Handicap Index - 30 assessing functional, physical and emotional scales
Swallowing quality of life
Time frame: Post-operative day 1
MD Anderson dysphagia inventory (MDADI)
Swallowing quality of life
Time frame: Post-operative 2 weeks
MD Anderson dysphagia inventory (MDADI)
Swallowing quality of life
Time frame: Post-operative 6 months
MD Anderson dysphagia inventory (MDADI)
Complication rate and types
Time frame: Post-operative 2 weeks
Lower lip numbness, skin bruising or injury, wound infection, vocal cord paralysis, temporary hypoparathyroidism
Complication rate and types
Time frame: Post-operative 6 months
Lower lip numbness, vocal cord paralysis, permanent hypoparathyroidism
4 secondary outcomes
Inpatient stay
Time frame: An average of 0-2 days after the operation
Operative time
Time frame: Intra-operatively
Blood loss
Time frame: Intra-operatively
Rate of conversion to open surgery
Time frame: Intra-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason YK Chan study director
Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong
Zenon Yeung principal investigator
Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transoral endoscopic thyroidectomy vestibular approach (TOETVA) and Traditional Open Thyroidectomy in people with Benign Thyroid Nodule and Suspicious Malignant Thyroid Nodule, run by Tseung Kwan O Hospital, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cherrie Ng (+85235051409, cherrieng@ent.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's satisfactory score (time frame: Post-operative day 1). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.