Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA)

NCT05412680 | Recruiting DMC

• 1 other identifier: TOETVA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Thyroid Diseases; Thyroid Cancer

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• Comparison on quality of life - questionnaire 1.

  1 year

• Comparison on quality of life - questionnaire 2.

  1 year

• Comparison on quality of life - questionnaire 3.

  1 year

Study Arms (2)

TOETVA

ACTIVE COMPARATOR

Patients submitted to transoral endoscopic thyroidectomy by vestibular approach

Procedure: TOETVA

CONVENTIONAL THYROIDECTOMY

ACTIVE COMPARATOR

Patients submitted to conventional open thyroidectomy by cervical approach

Procedure: conventional thyroidectomy

Interventions

TOETVA PROCEDURE

TRANSORAL ENDOSCOPIC THYROIDECTOMY BY VESTIBULAR APPROACH

TOETVA

conventional thyroidectomy PROCEDURE

conventional open thyroidectomy by cervical approach

CONVENTIONAL THYROIDECTOMY

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fábio de Aquino Capelli: lead

Study Sites (1)

ICESP

São Paulo, São Paulo, 01246000, Brazil

RECRUITING

MeSH Terms

Conditions

Thyroid Diseases; Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms

Study Officials

• Fabio Capelli, phd

  Instituto do Cancer do Estado de São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio Capelli, phd

CONTACT

55 11 98292-2288; fabiocapelli81@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: June 9, 2022
• Study Start: May 25, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-03

Locations

BR (1)