Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA) (TOETVA)

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

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

Study Overview

• Status: Recruiting
• Conditions: Thyroid Diseases; Thyroid Cancer
• Intervention / Treatment: Procedure: TOETVA; Procedure: conventional thyroidectomy

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)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabio Capelli, phd; Phone Number: 55 11 98292-2288; Email: fabiocapelli81@gmail.com

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 01246000
      • Recruiting
      • ICESP
      • Contact: Fabio Capelli, phd; Phone Number: 551198292-2288; Email: fabiocapelli81@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TOETVA; Patients submitted to transoral endoscopic thyroidectomy by vestibular approach	Procedure: TOETVA; TRANSORAL ENDOSCOPIC THYROIDECTOMY BY VESTIBULAR APPROACH
Active Comparator: CONVENTIONAL THYROIDECTOMY; Patients submitted to conventional open thyroidectomy by cervical approach	Procedure: conventional thyroidectomy; conventional open thyroidectomy by cervical approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare TOETVA technique with conventional thyroidectomy in terms of operative time	Operative time will be measured by minutes	1 year
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Comparison on quality of life - questionnaire 3.	Quality of life evaluated by specific questionnaires, such as Euroqol - 5D - 5 (better) 15 (worse)	1 year

Collaborators and Investigators

• Sponsor: Fábio de Aquino Capelli
• Investigators: Principal Investigator: Fabio Capelli, phd, Instituto do Cancer do Estado de Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: TOETVA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes