Status:
UNKNOWN
Total Thyroidectomy With Harmonic Scalpel®
Lead Sponsor:
Brazilian Society of Head and Neck Surgery
Collaborating Sponsors:
Johnson & Johnson
Conditions:
Thyroid Neoplasm
Goiter
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 sa...
Detailed Description
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. A...
Eligibility Criteria
Inclusion
- Adult (\>18 y/o)
- Benign or malignant thyroid disease
- Proposal of total thyroidectomy
- Normal thyroid function
Exclusion
- Giant goiter
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT00385983
Last Update
October 11 2006
Active Locations (9)
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1
Hospital Araujo Jorge
Goiânia, Goiás, Brazil
2
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
3
Instituto Nacional de Cancer INCA
Rio de Janeiro, Rio de Janeiro, Brazil
4
Hospital do Cancer de Natal
Natal, Rio Grande do Norte, Brazil