Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA)
NCT ID: NCT05412680
Last Updated: 2024-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2022-05-25
2024-12-31
Brief Summary
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Detailed Description
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* Conventional Thyroidectomy (30 patients)
* Transoral Endoscopic Thyroidectomy By Vestibular Approach (30 patients)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TOETVA
Patients submitted to transoral endoscopic thyroidectomy by vestibular approach
TOETVA
TRANSORAL ENDOSCOPIC THYROIDECTOMY BY VESTIBULAR APPROACH
CONVENTIONAL THYROIDECTOMY
Patients submitted to conventional open thyroidectomy by cervical approach
conventional thyroidectomy
conventional open thyroidectomy by cervical approach
Interventions
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TOETVA
TRANSORAL ENDOSCOPIC THYROIDECTOMY BY VESTIBULAR APPROACH
conventional thyroidectomy
conventional open thyroidectomy by cervical approach
Eligibility Criteria
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Inclusion Criteria
* 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
* evidence of clinical hyperthyroidism
* preoperative recurrent nerve palsy
* lymph node metastasis
* extra-thyroid extension
* plunging goiter
* oral abscess
18 Years
70 Years
ALL
No
Sponsors
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Fábio de Aquino Capelli
OTHER
Responsible Party
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Fábio de Aquino Capelli
Principal Investigator
Principal Investigators
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Fabio Capelli, phd
Role: PRINCIPAL_INVESTIGATOR
Instituto do Cancer do Estado de São Paulo
Locations
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ICESP
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TOETVA
Identifier Type: -
Identifier Source: org_study_id
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