Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA)

Fábio de Aquino Capelli

Status: Enrolling

Conditions: Thyroid Diseases; Thyroid Cancer

Treatments: Procedure: TOETVA; Procedure: conventional thyroidectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05412680

TOETVA

Details and patient eligibility

About

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

Full 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)

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

TOETVA

Active Comparator group

Description:

Patients submitted to transoral endoscopic thyroidectomy by vestibular approach

Treatment:

Procedure: TOETVA

CONVENTIONAL THYROIDECTOMY

Active Comparator group

Description:

Patients submitted to conventional open thyroidectomy by cervical approach

Treatment:

Procedure: conventional thyroidectomy