Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA)

Thyroid Cancer Clinical Trial

— TOETVA  

Official title:

Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA) Compared to Conventional Thyroidectomy by Cervical Approach: a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05412680
• Other study ID #: TOETVA
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2022
• 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
• 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, 2023
• Est. primary completion date: December 31, 2023
• 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

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

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