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Prospective study carried out with ICESP (instituto do Câncer do Estado de São Paulo) patients with thyroid disease with surgical indication
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TOETVA | Active Comparator | Patients submitted to transoral endoscopic thyroidectomy by vestibular approach |
|
| CONVENTIONAL THYROIDECTOMY | Active Comparator | Patients submitted to conventional open thyroidectomy by cervical approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOETVA | Procedure | TRANSORAL ENDOSCOPIC THYROIDECTOMY BY VESTIBULAR APPROACH |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To compare TOETVA technique with conventional thyroidectomy in terms of operative time | 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 | 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 | 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 | 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 | 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 | This outcome will be accessed by qualitative analysis | 1 year |
| To compare TOETVA technique with conventional thyroidectomy in terms of post operative pain |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 year |
| Comparison on quality of life - questionnaire 2. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabio Capelli, phd | Contact | 55 11 98292-2288 | fabiocapelli81@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Fabio Capelli, phd | Instituto do Cancer do Estado de São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICESP | Recruiting | São Paulo | São Paulo | 01246000 | Brazil |
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| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| conventional thyroidectomy |
| Procedure |
conventional open thyroidectomy by cervical approach |
|
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 | This outcome will be accessed by number of days spent in the hospital | 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. | Quality of life evaluated by specific questionnaires, such as Euroqol - 5D - 5 (better) 15 (worse) | 1 year |
| D006258 |
| Head and Neck Neoplasms |