Harmonic Scalpel vs. Electrocautery in Modified Radical Neck Dissection: A Single Blinded Prospective Randomized Trial
Patients who are referred to either the clinic of Dr. Joseph Dort or Dr. Wayne Matthews and
are deemed to benefit from a modified radical neck dissection alone or as part of treatment
for head and neck cancer will be given an opportunity to be a subject in this study. Once
informed consent for both the surgery and the study is obtained, the lead author will be
contacted and randomization will occur using a computer generated block-randomization
allocation. The neck dissection will be carried out in the operating room using either
electrocautery (control group) or harmonic scalpel (experimental group). The primary
outcomes, blood loss (mLs) and operative time (minutes) will be assessed at the time of
surgery. The blood loss in milliliters will be calculated using suction canister output,
weight of sponges and irrigation used. The operative time in minutes will be calculated
between the beginning of the actual neck dissection to the completion of the neck dissection
defined as the removal of the surgical specimen and hemostasis of the surgical field.
Intraoperative complications, namely vascular, nerve damage and lymphatic damage will be
assessed at the time of surgery. Post-operative complications, both early and late will be
assessed after the surgery using the Clavien post-operative complication scale. In
addition, the length of time that operative drains are left in the neck will be measured
with all drains being removed when their 24 hour drain output is less than 20 mls. Patients
will then be followed up 2 weeks after their hospital discharge in the surgeon's clinic or
the Tom Baker Cancer Centre.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
operative blood loss
intraoperative
No
Joseph C Dort, BSc, MSc, MD
Principal Investigator
University of Calgary - Faculty of Medicine
Canada: Ethics Review Committee
UCENT003
NCT00875953
January 2009
December 2010
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