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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
Harmonic scalpel is a new surgical instrument. Its use has been recommended in patients submitted to total thyroidectomy. Few randomized controlled trials has been published. However they had small sample sizes, used intermediate outcomes and included different surgical procedures.
Our objective is to asses the use of Harmonic scalpel in patients submitted to total thyroidectomy using surgical complications, operative time, drainage volume, postoperative pain, length of stay and costs as outcomes. Our hypothesis is that Harmonic scalpel decreases operative time,drainage volume, postoperative pain, length of stay and costs without increasing surgical complications
This is a multicentric open phase IV randomized controlled trial comparing patients submitted to total thyroidectomy comparing standard surgical procedure versus Harmonic scalpel assisted procedure. Adult patients with benign or malignant thyroid disease and normal function will be included. Patients with giant goiter, hyperthyroidism, non differentiated thyroid carcinoma, locally invasive tumors, neck dissection, previous neck radiotherapy or chemotherapy, video assisted surgery and severe comorbidities will be excluded. calculated sample size was 280 patients. Outcomes will be assessed by an independent monitor. All centers will made a previous standardization of surgical procedures.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Harmonic Scalpel | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | ||
| Drainage volume | ||
| Postoperative pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luiz P Kowalski, PhD | Contact | 55-11-33410325 | lp_kowalski@uol.com.br | |
| Andre L Carvalho | Contact | alopescarvalho@uol.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Luiz P Kowalski, PhD | Brazilian Society of Head and Neck Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Araujo Jorge | Goiânia | Goiás | Brazil |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D006042 | Goiter |
| D016606 | Thyroid Nodule |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| Length of stay |
| Direct Costs |
| Hospital Erasto Gaertner | Curitiba | Paraná | Brazil |
|
| Instituto Nacional de Cancer INCA | Rio de Janeiro | Rio de Janeiro | Brazil |
|
| Hospital do Cancer de Natal | Natal | Rio Grande do Norte | Brazil |
|
| Hospital do Cancer AC Camargo | São Paulo | São Paulo | Brazil |
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| Hospital Heliopolis | São Paulo | São Paulo | Brazil |
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| Hospital Sao Paulo-UNIFESP | São Paulo | São Paulo | Brazil |
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| Instituto Arnaldo Vieira de Carvalho | São Paulo | São Paulo | Brazil |
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| Santa Casa de Misericordia | São Paulo | São Paulo | Brazil |
|
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |