The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection : A Prospective Randomized Study
N/A
18 Years
90 Years
18 Years
90 Years
Open (Enrolling)
Both
Head and Neck Cancer
Both
Head and Neck Cancer
Trial Information
The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection : A Prospective Randomized Study
Inclusion Criteria:
- preoperative diagnosis of head and neck squamous cell carcinoma
- surgery as initial treatment
Exclusion Criteria:
- cases in which the ND specimen could not be separated from the primary tumor
- past history of neck surgery
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
number of harvested lymph nodes
Outcome Description:
number of harvested lymph nodes counted from the lymphfatty tissue after neck dissection
Outcome Time Frame:
when the pathologist examine the specimen which is within 1 week after operation
Safety Issue:
Yes
Authority:
Korea: Food and Drug Administration
Study ID:
1-2011-0014
NCT ID:
NCT01488682
Start Date:
January 2010
Completion Date:
December 2012
Related Keywords:
- Head and Neck Cancer
- Head and neck cancer
- Neck dissection
- Harmonic scalpel
- Head and Neck Neoplasms
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