Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA)

• Sponsor: Fábio de Aquino Capelli (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05412680
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19.2
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Thyroid Diseases; Thyroid Cancer	Procedure: TOETVA; Procedure: conventional thyroidectomy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA) Compared to Conventional Thyroidectomy by Cervical Approach: a Randomized Clinical Trial
• Actual Study Start Date: May 25, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. To compare TOETVA technique with conventional thyroidectomy in terms of operative time [1 year]

   Operative time will be measured by minutes

2. To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as laryngeal nerve dysfunction [1 year]

   This outcome will be accessed by performing laryngoscopy before and after the surgery

3. To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as hypoparathyroidism [1 year]

   This outcome will be accessed by accessing de blood calcium and parathormone levels after the surgery

4. To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as hematoma formation [1 year]

   This outcome will be accessed by qualitative analysis

5. To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as seroma formation [1 year]

   This outcome will be accessed by qualitative analysis

6. To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as skin injury [1 year]

   This outcome will be accessed by qualitative analysis

7. To compare TOETVA technique with conventional thyroidectomy in terms of post operative pain [1 year]

   This outcome will be accessed by visual pain scale from grade 1 (better) to 10 (worse)

8. To compare TOETVA technique with conventional thyroidectomy in terms of time of hospitalization [1 year]

   This outcome will be accessed by number of days spent in the hospital

Secondary Outcome Measures

1. Comparison on quality of life - questionnaire 1. [1 year]

   Quality of life evaluated by specific questionnaires, such as University of Washington version 4 - 0 (worse) 1200 (better)

2. Comparison on quality of life - questionnaire 2. [1 year]

   Quality of life evaluated by specific questionnaires, such as Dermatology life quality index - 0 (better) 30 (worse)

3. Comparison on quality of life - questionnaire 3. [1 year]

   Quality of life evaluated by specific questionnaires, such as Euroqol - 5D - 5 (better) 15 (worse)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ICESP	São Paulo	SP	Brazil	01246000

Sponsors and Collaborators

• Fábio de Aquino Capelli

Investigators

• Principal Investigator: Fabio Capelli, phd, Instituto do Cancer do Estado de São Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fábio de Aquino Capelli, Principal Investigator, Instituto do Cancer do Estado de São Paulo
• ClinicalTrials.gov Identifier: NCT05412680
• Other Study ID Numbers: TOETVA
• First Posted: Jun 9, 2022
• Last Update Posted: Jun 9, 2022
• Last Verified: Jun 1, 2022

• 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
• Additional relevant MeSH terms: Thyroid Neoplasms; Thyroid Diseases

Study Results

No Results Posted as of Jun 9, 2022