Status:
RECRUITING
Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA)
Lead Sponsor:
Fábio de Aquino Capelli
Conditions:
Thyroid Diseases
Thyroid Cancer
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 tw...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05412680
Start Date
May 25 2022
End Date
December 31 2024
Last Update
May 14 2024
Active Locations (1)
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1
ICESP
São Paulo, São Paulo, Brazil, 01246000