Back to resultsTransoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA) (TOETVA)
Primary Purpose
Thyroid Diseases, Thyroid Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
TOETVA
conventional thyroidectomy
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Diseases
Eligibility Criteria
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
Sites / Locations
- ICESPRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
TOETVA
CONVENTIONAL THYROIDECTOMY
Arm Description
Patients submitted to transoral endoscopic thyroidectomy by vestibular approach
Patients submitted to conventional open thyroidectomy by cervical approach
Outcomes
Primary Outcome Measures
To compare TOETVA technique with conventional thyroidectomy in terms of operative time
Operative time will be measured by minutes
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
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
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
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
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
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)
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
Secondary Outcome Measures
Comparison on quality of life - questionnaire 1.
Quality of life evaluated by specific questionnaires, such as University of Washington version 4 - 0 (worse) 1200 (better)
Comparison on quality of life - questionnaire 2.
Quality of life evaluated by specific questionnaires, such as Dermatology life quality index - 0 (better) 30 (worse)
Comparison on quality of life - questionnaire 3.
Quality of life evaluated by specific questionnaires, such as Euroqol - 5D - 5 (better) 15 (worse)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05412680
Brief Title
Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA)
Acronym
TOETVA
Official Title
Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA) Compared to Conventional Thyroidectomy by Cervical Approach: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fábio de Aquino Capelli
4. Oversight
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
Data Monitoring Committee
Yes
5. 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
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Diseases, Thyroid Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TOETVA
Arm Type
Active Comparator
Arm Description
Patients submitted to transoral endoscopic thyroidectomy by vestibular approach
Arm Title
CONVENTIONAL THYROIDECTOMY
Arm Type
Active Comparator
Arm Description
Patients submitted to conventional open thyroidectomy by cervical approach
Intervention Type
Procedure
Intervention Name(s)
TOETVA
Intervention Description
TRANSORAL ENDOSCOPIC THYROIDECTOMY BY VESTIBULAR APPROACH
Intervention Type
Procedure
Intervention Name(s)
conventional thyroidectomy
Intervention Description
conventional open thyroidectomy by cervical approach
Primary Outcome Measure Information:
Title
To compare TOETVA technique with conventional thyroidectomy in terms of operative time
Description
Operative time will be measured by minutes
Time Frame
1 year
Title
To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as laryngeal nerve dysfunction
Description
This outcome will be accessed by performing laryngoscopy before and after the surgery
Time Frame
1 year
Title
To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as hypoparathyroidism
Description
This outcome will be accessed by accessing de blood calcium and parathormone levels after the surgery
Time Frame
1 year
Title
To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as hematoma formation
Description
This outcome will be accessed by qualitative analysis
Time Frame
1 year
Title
To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as seroma formation
Description
This outcome will be accessed by qualitative analysis
Time Frame
1 year
Title
To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as skin injury
Description
This outcome will be accessed by qualitative analysis
Time Frame
1 year
Title
To compare TOETVA technique with conventional thyroidectomy in terms of post operative pain
Description
This outcome will be accessed by visual pain scale from grade 1 (better) to 10 (worse)
Time Frame
1 year
Title
To compare TOETVA technique with conventional thyroidectomy in terms of time of hospitalization
Description
This outcome will be accessed by number of days spent in the hospital
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Comparison on quality of life - questionnaire 1.
Description
Quality of life evaluated by specific questionnaires, such as University of Washington version 4 - 0 (worse) 1200 (better)
Time Frame
1 year
Title
Comparison on quality of life - questionnaire 2.
Description
Quality of life evaluated by specific questionnaires, such as Dermatology life quality index - 0 (better) 30 (worse)
Time Frame
1 year
Title
Comparison on quality of life - questionnaire 3.
Description
Quality of life evaluated by specific questionnaires, such as Euroqol - 5D - 5 (better) 15 (worse)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabio Capelli, phd
Phone
55 11 98292-2288
Email
fabiocapelli81@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio Capelli, phd
Organizational Affiliation
Instituto do Cancer do Estado de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICESP
City
São Paulo
State/Province
SP
ZIP/Postal Code
01246000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabio Capelli, phd
Phone
551198292-2288
Email
fabiocapelli81@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA)
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