Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
280 participants
INTERVENTIONAL
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Interventions
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Harmonic Scalpel
Eligibility Criteria
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Inclusion Criteria
* Benign or malignant thyroid disease
* Proposal of total thyroidectomy
* Normal thyroid function
Exclusion Criteria
* Hyperthyroidism
* Non differentiated thyroid carcinoma
* Locally invasive tumors
* Neck dissection as a part of procedure
* Previous surgery, radiotherapy or I131 therapy on neck
* Video-assisted or endoscopic thyroidectomy
* Severe comorbidities
* Coagulation disorders
18 Years
ALL
No
Sponsors
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Johnson & Johnson
INDUSTRY
Brazilian Society of Head and Neck Surgery
OTHER
Principal Investigators
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Luiz P Kowalski, PhD
Role: PRINCIPAL_INVESTIGATOR
Brazilian Society of Head and Neck Surgery
Locations
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Hospital Araujo Jorge
Goiânia, Goiás, Brazil
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
Hospital Heliopolis
São Paulo, São Paulo, Brazil
Hospital Sao Paulo-UNIFESP
São Paulo, São Paulo, Brazil
Instituto Arnaldo Vieira de Carvalho
São Paulo, São Paulo, Brazil
Santa Casa de Misericordia
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Other Identifiers
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CP005
Identifier Type: -
Identifier Source: org_study_id