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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date March 2024
Source Instituto do Cancer do Estado de São Paulo
Contact Fabio Capelli, phd
Phone 55 11 98292-2288
Email fabiocapelli81@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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)


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
TOETVA
TRANSORAL ENDOSCOPIC THYROIDECTOMY BY VESTIBULAR APPROACH
conventional thyroidectomy
conventional open thyroidectomy by cervical approach

Locations

Country Name City State
Brazil ICESP São Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
Fábio de Aquino Capelli

Country where clinical trial is conducted

Brazil, 

Outcome

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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