Thyroid Cancer Clinical Trial
— TOETVAOfficial title:
Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA) Compared to Conventional Thyroidectomy by Cervical Approach: a Randomized Clinical Trial
NCT number | NCT05412680 |
Other study ID # | TOETVA |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 25, 2022 |
Est. completion date | December 31, 2024 |
Prospective study carried out with ICESP (instituto do Câncer do Estado de São Paulo) patients with thyroid disease with surgical indication
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Brazil | ICESP | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
Fábio de Aquino Capelli |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare TOETVA technique with conventional thyroidectomy in terms of operative time | Operative time will be measured by minutes | 1 year | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Comparison on quality of life - questionnaire 3. | Quality of life evaluated by specific questionnaires, such as Euroqol - 5D - 5 (better) 15 (worse) | 1 year |
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