Use of the Harmonic Scalpel in Neck Dissection

Harmonic Scalpel vs. Electrocautery in Modified Radical Neck Dissection: A Single Blinded Prospective Randomized Trial

Neck dissection is the main technique used by head and neck surgeons to treat known or suspected metastatic cancer to the neck. The traditional radical neck dissection was effective at treating metastatic cancer to the neck however the downside to this technique was significant morbidity. Since the early 1960's there has been several proposed techniques to treat metastatic head and neck cancer that involves preserving important anatomical structures in the neck. The disadvantage to these techniques are that they require meticulous dissection and can lead to bleeding and an increase in operative time. One particular tool that has been proposed in other surgical subspecialties, including head and neck surgery, is the harmonic scalpel. Using this tool, tissue dissection and vessel occlusion at the same time can occur with a reduced thermal damage to the surrounding tissue when compared to traditional cautery. In this study, our purpose is to determine if the harmonic scalpel will lead to a decrease in blood loss and operative time in patients undergoing a modified radical neck dissection compared to electrocautery.

Hypothesis: Use of the harmonic scalpel as a surgical adjunct will reduce operative time for neck dissection and will reduce intraoperative blood loss.

Study Overview

• Status: Completed
• Conditions: Neck Dissection
• Intervention / Treatment: Procedure: standard neck dissection; Procedure: Harmonic Scalpel Dissection

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • Foothills Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age > 18 years
• undergoing neck dissection (levels I-IV)

Exclusion Criteria:

• no prior head and neck surgery
• no prior head and neck cancer
• no prior head and neck radiation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Standard dissection; standard neck dissection technique: scalpel and cautery.	Procedure: standard neck dissection; standard surgical technique
EXPERIMENTAL: Harmonic Scalpel; Harmonic scalpel used in neck dissection.	Procedure: Harmonic Scalpel Dissection; harmonic scalpel used for neck dissection after flaps are raised.; Other Names: ethicon harmonic scalpel used

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
operative blood loss	intraoperative
Operating Time	at end of the procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
wound drainage	48 hours
wound infection	48 hours, 1 week

Collaborators and Investigators

• Sponsor: University of Calgary
• Investigators: Principal Investigator: Joseph C Dort, BSc, MSc, MD, University of Calgary - Faculty of Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): September 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: April 3, 2009
• First Submitted That Met QC Criteria: April 3, 2009
• First Posted (ESTIMATE): April 6, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): December 14, 2010
• Last Update Submitted That Met QC Criteria: December 13, 2010
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: head and neck cancer; squamous cell carcinoma; neck dissection
• Other Study ID Numbers: UCENT003