- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05412680
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
Status
Recruiting
Conditions
Intervention / Treatment
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
- Name: Fabio Capelli, phd
- Phone Number: 55 11 98292-2288
- Email: fabiocapelli81@gmail.com
Study Locations
-
-
SP
-
São Paulo, SP, Brazil, 01246000
- Recruiting
- ICESP
-
Contact:
- Fabio Capelli, phd
- Phone Number: 551198292-2288
- Email: fabiocapelli81@gmail.com
-
-
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.
Sponsor
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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