Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA)

Study Overview
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Brief Summary
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Prospective study carried out with ICESP (instituto do Câncer do Estado de São Paulo) patients with thyroid disease with surgical indication

Detailed Description
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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)

Official Title
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Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA) Compared to Conventional Thyroidectomy by Cervical Approach: a Randomized Clinical Trial

Conditions
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Thyroid Diseases, Thyroid Cancer

Intervention / Treatment
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* Procedure: TOETVA
* Procedure: conventional thyroidectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TOETVA<br>Patients submitted to transoral endoscopic thyroidectomy by vestibular approach | Procedure: TOETVA<br>* TRANSORAL ENDOSCOPIC THYROIDECTOMY BY VESTIBULAR APPROACH<br>|
| Active Comparator: CONVENTIONAL THYROIDECTOMY<br>Patients submitted to conventional open thyroidectomy by cervical approach | Procedure: conventional thyroidectomy<br>* conventional open thyroidectomy by cervical approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare TOETVA technique with conventional thyroidectomy in terms of operative time | Operative time will be measured by minutes | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 1 year | 
| Comparison on quality of life - questionnaire 3. | Quality of life evaluated by specific questionnaires, such as Euroqol - 5D - 5 (better) 15 (worse) | 1 year |