Thyroid DiseasesTOETVANCT05412680
Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA)
A study testing TOETVA and conventional thyroidectomy in people with Thyroid Diseases and Thyroid Cancer, run by Fábio de Aquino Capelli at 1 site in Brazil.
Trial summary
Prospective study carried out with ICESP (instituto do Câncer do Estado de São Paulo) patients with thyroid disease with surgical indication Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroid Diseases, Thyroid Cancer
- What is being tested?
- TOETVA and conventional thyroidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 25 May 2022to 31 Dec 2024
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- history of hypertrophic scarring and/or motivation to avoid cervical scarring,
- maximum diameter of the thyroid < 10 cm and of the dominant nodule < 6 cm,
- estimated thyroid volume < 45 ml
- benign lesion (multinodular goiter, cyst),
- indeterminate nodule (Bethesda III or IV),
- suspicious nodule for well-differentiated thyroid carcinoma (Bethesda V and VI) < 2 cm
Who cannot join
- history of previous surgery or irradiation in the head and neck region and superior mediastinum
- evidence of clinical hyperthyroidism
- preoperative recurrent nerve palsy
- lymph node metastasis
- extra-thyroid extension
- plunging goiter
- oral abscess
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
ICESP
São Paulo, São Paulo, 01246000
Fabio Capelli, phd, 551198292-2288, fabiocapelli81@gmail.com
About this study
Official title: Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA) Compared to Conventional Thyroidectomy by Cervical Approach: a Randomized Clinical Trial
Prospective study carried out with ICESP (instituto do Câncer do Estado de São Paulo) patients with thyroid disease with surgical indication
Read the detailed description
Prospective study carried out with ICESP patients with thyroid disease with surgical indication, according to the aforementioned inclusion criteria, totaling 60 cases, which will be randomized into two groups:
- Conventional Thyroidectomy (30 patients)
- Transoral Endoscopic Thyroidectomy By Vestibular Approach (30 patients)
- Conditions
- Thyroid Diseases, Thyroid Cancer
- Being tested
- TOETVA, conventional thyroidectomy
- Medical subject headings
- Thyroid Diseases, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOETVAProcedure or surgery
TRANSORAL ENDOSCOPIC THYROIDECTOMY BY VESTIBULAR APPROACH
conventional thyroidectomyProcedure or surgery
conventional open thyroidectomy by cervical approach
| Study group | Role | What they receive |
|---|---|---|
| TOETVA | Active comparator | Patients submitted to transoral endoscopic thyroidectomy by vestibular approach Receives: Procedure: TOETVA |
| CONVENTIONAL THYROIDECTOMY | Active comparator | Patients submitted to conventional open thyroidectomy by cervical approach Receives: Procedure: conventional thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare TOETVA technique with conventional thyroidectomy in terms of operative time
Operative time will be measured by minutes
Measured: 1 year
To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as laryngeal nerve dysfunction
This outcome will be accessed by performing laryngoscopy before and after the surgery
Measured: 1 year
To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as hypoparathyroidism
This outcome will be accessed by accessing de blood calcium and parathormone levels after the surgery
Measured: 1 year
To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as hematoma formation
This outcome will be accessed by qualitative analysis
Measured: 1 year
To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as seroma formation
This outcome will be accessed by qualitative analysis
Measured: 1 year
To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as skin injury
This outcome will be accessed by qualitative analysis
Measured: 1 year
To compare TOETVA technique with conventional thyroidectomy in terms of post operative pain
This outcome will be accessed by visual pain scale from grade 1 (better) to 10 (worse)
Measured: 1 year
To compare TOETVA technique with conventional thyroidectomy in terms of time of hospitalization
This outcome will be accessed by number of days spent in the hospital
Measured: 1 year
Secondary outcomes (3)
Comparison on quality of life - questionnaire 1.
Quality of life evaluated by specific questionnaires, such as University of Washington version 4 - 0 (worse) 1200 (better)
Measured: 1 year
Comparison on quality of life - questionnaire 2.
Quality of life evaluated by specific questionnaires, such as Dermatology life quality index - 0 (better) 30 (worse)
Measured: 1 year
Comparison on quality of life - questionnaire 3.
Quality of life evaluated by specific questionnaires, such as Euroqol - 5D - 5 (better) 15 (worse)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start25 May 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DiseasesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fábio de Aquino Capelli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fábio de Aquino Capelli, Instituto do Cancer do Estado de São Paulo
- Investigators
- Fabio Capelli, phd, Principal investigator, Instituto do Cancer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412680
- Sponsor's protocol ID
- TOETVA
- Acronym
- TOETVA
- Status last verified
- Mar 2024
- First submitted
- 18 May 2022
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA) Compared to Conventional Thyroidectomy by Cervical Approach: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05412680
- Acronym / sponsor ID
- TOETVA / TOETVA
- Conditions
- Thyroid Diseases, Thyroid Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fábio de Aquino CapelliUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Jun 2022 (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.
Prospective study carried out with ICESP (instituto do Câncer do Estado de São Paulo) patients with thyroid disease with surgical indication
Detailed description
Prospective study carried out with ICESP patients with thyroid disease with surgical indication, according to the aforementioned inclusion criteria, totaling 60 cases, which will be randomized into two groups:
- Conventional Thyroidectomy (30 patients)
- Transoral Endoscopic Thyroidectomy By Vestibular Approach (30 patients)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TOETVA | Active comparator | Procedure: TOETVAPatients submitted to transoral endoscopic thyroidectomy by vestibular approach |
| CONVENTIONAL THYROIDECTOMY | Active comparator | Procedure: conventional thyroidectomyPatients submitted to conventional open thyroidectomy by cervical approach |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- history of hypertrophic scarring and/or motivation to avoid cervical scarring,
- maximum diameter of the thyroid < 10 cm and of the dominant nodule < 6 cm,
- estimated thyroid volume < 45 ml
- benign lesion (multinodular goiter, cyst),
- indeterminate nodule (Bethesda III or IV),
Key exclusion criteria (7 listed)
- history of previous surgery or irradiation in the head and neck region and superior mediastinum
- evidence of clinical hyperthyroidism
- preoperative recurrent nerve palsy
- lymph node metastasis
- extra-thyroid extension
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 |
|---|---|---|
| TOETVATRANSORAL ENDOSCOPIC THYROIDECTOMY BY VESTIBULAR APPROACH | Procedure or surgery | TOETVA |
| conventional thyroidectomyconventional open thyroidectomy by cervical approach | Procedure or surgery | CONVENTIONAL THYROIDECTOMY |
Primary outcome
To compare TOETVA technique with conventional thyroidectomy in terms of operative time
Time frame: 1 year
Operative time will be measured by minutes
To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as laryngeal nerve dysfunction
Time frame: 1 year
This outcome will be accessed by performing laryngoscopy before and after the surgery
To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as hypoparathyroidism
Time frame: 1 year
This outcome will be accessed by accessing de blood calcium and parathormone levels after the surgery
To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as hematoma formation
Time frame: 1 year
This outcome will be accessed by qualitative analysis
To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as seroma formation
Time frame: 1 year
This outcome will be accessed by qualitative analysis
To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as skin injury
Time frame: 1 year
This outcome will be accessed by qualitative analysis
To compare TOETVA technique with conventional thyroidectomy in terms of post operative pain
Time frame: 1 year
This outcome will be accessed by visual pain scale from grade 1 (better) to 10 (worse)
To compare TOETVA technique with conventional thyroidectomy in terms of time of hospitalization
Time frame: 1 year
This outcome will be accessed by number of days spent in the hospital
3 secondary outcomes
Comparison on quality of life - questionnaire 1.
Time frame: 1 year
Comparison on quality of life - questionnaire 2.
Time frame: 1 year
Comparison on quality of life - questionnaire 3.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
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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.
Fabio Capelli, phd principal investigator
Instituto do Cancer do Estado de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TOETVA and conventional thyroidectomy in people with Thyroid Diseases and Thyroid Cancer, run by Fábio de Aquino Capelli at 1 site in Brazil.
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 6 inclusion and 7 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 14 May 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 Brazil. 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 Fabio Capelli, phd (55 11 98292-2288, fabiocapelli81@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare TOETVA technique with conventional thyroidectomy in terms of operative time (time frame: 1 year). The study lists 8 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 14 May 2024.