The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
Head and neck cancer, Neck dissection, Harmonic scalpel
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Intervention
Name: Neck dissection with Harmonic scalpel Type: Procedure
Name: neck dissection with conventional hand-tie ligation Type: Procedure
Overall Status
Recruiting
Summary
Recently, the HS has been used in head and neck surgery as an alternative to conventional hand-tied ligation for hemostasis, which is a time-consuming procedure. Limited data have been published on the evidence of its safety in ND, especially in radical ND. Researchers investigated the safety and efficacy of the Harmonic scalpel (HS) in neck dissection (ND), while using conventional hand-tied ligation to a minimum, in terms of operating time, blood loss, drainage and complications.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 90 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Yonsei University Severance Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Yoon Woo Koh, MD, PhD - 82-10-9097-0955 - ywkohent@yuhs.ac
Start Date
January 2010
Completion Date
December 2012
Sponsors
Yonsei University
Source
Yonsei University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page