Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA) Compared to Conventional Thyroidectomy by Cervical Approach: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as laryngeal nerve dysfunction
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
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
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
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
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)
To compare TOETVA technique with conventional thyroidectomy in terms of operative time
Time Frame: 1 year
Operative time will be measured by minutes
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
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
Secondary Outcomes
- 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)
Investigators
Fábio de Aquino Capelli
Principal Investigator
Instituto do Cancer do Estado de São Paulo