Thyroid Cancer, Thyroid Diseases
Conditions
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)
Interventions
PROCEDURETOETVA
TRANSORAL ENDOSCOPIC THYROIDECTOMY BY VESTIBULAR APPROACH
PROCEDUREconventional thyroidectomy
conventional open thyroidectomy by cervical approach
Sponsors
Fábio de Aquino Capelli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare TOETVA technique with conventional thyroidectomy in terms of time of hospitalization | 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 surgical complications, such as seroma formation | 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 skin injury | 1 year | This outcome will be accessed by qualitative analysis |
| To compare TOETVA technique with conventional thyroidectomy in terms of post operative pain | 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 | 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 laryngeal nerve dysfunction | 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 hypoparathyroidism | 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 | 1 year | This outcome will be accessed by qualitative analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison on quality of life - questionnaire 2. | 1 year | Quality of life evaluated by specific questionnaires, such as Dermatology life quality index - 0 (better) 30 (worse) |
| Comparison on quality of life - questionnaire 3. | 1 year | Quality of life evaluated by specific questionnaires, such as Euroqol - 5D - 5 (better) 15 (worse) |
| Comparison on quality of life - questionnaire 1. | 1 year | Quality of life evaluated by specific questionnaires, such as University of Washington version 4 - 0 (worse) 1200 (better) |
Countries
Brazil
Contacts
Primary ContactFabio Capelli, phd
Outcome results
None listed