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

June 7, 2022 updated by: Fábio de Aquino Capelli

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

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 (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • SP
      • São Paulo, SP, Brazil, 01246000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: TOETVA
Patients submitted to transoral endoscopic thyroidectomy by vestibular approach
TRANSORAL ENDOSCOPIC THYROIDECTOMY BY VESTIBULAR APPROACH
ACTIVE_COMPARATOR: CONVENTIONAL THYROIDECTOMY
Patients submitted to conventional open thyroidectomy by cervical approach
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
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year
This outcome will be accessed by qualitative analysis
1 year
To compare TOETVA technique with conventional thyroidectomy in terms of post operative pain
Time Frame: 1 year
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
Time Frame: 1 year
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.
Time Frame: 1 year
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.
Time Frame: 1 year
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.
Time Frame: 1 year
Quality of life evaluated by specific questionnaires, such as Euroqol - 5D - 5 (better) 15 (worse)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 25, 2022

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2023

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)

June 9, 2022

Last Update Submitted That Met QC Criteria

June 7, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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