Clinical trial NCT05412680: Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA)
Official title: Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA) Compared to Conventional Thyroidectomy by Cervical Approach: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thyroid Diseases
Thyroid Cancer
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 two groups:

* Conventional Thyroidectomy (30 patients)
* Transoral Endoscopic Thyroidectomy By Vestibular Approach (30 patients)

Eligibility criteria: 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

Primary outcomes:
measure: To compare TOETVA technique with conventional thyroidectomy in terms of operative time
timeFrame: 1 year
measure: To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as laryngeal nerve dysfunction
timeFrame: 1 year
measure: To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as hypoparathyroidism
timeFrame: 1 year
measure: To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as hematoma formation
timeFrame: 1 year
measure: To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as seroma formation
timeFrame: 1 year
measure: To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as skin injury
timeFrame: 1 year
measure: To compare TOETVA technique with conventional thyroidectomy in terms of post operative pain
timeFrame: 1 year
measure: To compare TOETVA technique with conventional thyroidectomy in terms of time of hospitalization
timeFrame: 1 year
Secondary outcomes:
measure: Comparison on quality of life - questionnaire 1.
timeFrame: 1 year
measure: Comparison on quality of life - questionnaire 2.
timeFrame: 1 year
measure: Comparison on quality of life - questionnaire 3.
timeFrame: 1 year
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: ICESP
state: SP
Study officials:
affiliation: Instituto do Cancer do Estado de São Paulo
name: Fabio Capelli, phd
role: PRINCIPAL_INVESTIGATOR
References: