Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA)

NCT ID: NCT05412680

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-25

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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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)

Conditions

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Thyroid Diseases Thyroid Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TOETVA

Patients submitted to transoral endoscopic thyroidectomy by vestibular approach

Group Type ACTIVE_COMPARATOR

TOETVA

Intervention Type PROCEDURE

TRANSORAL ENDOSCOPIC THYROIDECTOMY BY VESTIBULAR APPROACH

CONVENTIONAL THYROIDECTOMY

Patients submitted to conventional open thyroidectomy by cervical approach

Group Type ACTIVE_COMPARATOR

conventional thyroidectomy

Intervention Type PROCEDURE

conventional open thyroidectomy by cervical approach

Interventions

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TOETVA

TRANSORAL ENDOSCOPIC THYROIDECTOMY BY VESTIBULAR APPROACH

Intervention Type PROCEDURE

conventional thyroidectomy

conventional open thyroidectomy by cervical approach

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fábio de Aquino Capelli

OTHER

Sponsor Role lead

Responsible Party

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Fábio de Aquino Capelli

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Fabio Capelli, phd

Role: PRINCIPAL_INVESTIGATOR

Instituto do Cancer do Estado de São Paulo

Locations

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ICESP

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Fabio Capelli, phd

Role: CONTACT

55 11 98292-2288

Facility Contacts

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Fabio Capelli, phd

Role: primary

551198292-2288

Other Identifiers

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TOETVA

Identifier Type: -

Identifier Source: org_study_id

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