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Use of the Harmonic Scalpel in Neck Dissection

This study has been completed.
Sponsor:
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00875953
First received: April 3, 2009
Last updated: December 13, 2010
Last verified: April 2009
History of Changes
  Purpose

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.


Condition Intervention
Neck Dissection
 Procedure: standard neck dissection
Procedure: Harmonic Scalpel Dissection

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Harmonic Scalpel vs. Electrocautery in Modified Radical Neck Dissection: A Single Blinded Prospective Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • operative blood loss [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
  • Operating Time [ Time Frame: at end of the procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • wound drainage [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • wound infection [ Time Frame: 48 hours, 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 34
Study Start Date: January 2009
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: ethicon harmonic scalpel used

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875953

Locations
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 4N1
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Joseph C Dort, BSc, MSc, MD University of Calgary - Faculty of Medicine
  More Information

No publications provided

Responsible Party: Joseph C. Dort BSc, MSc, MD, University of Calgary
ClinicalTrials.gov Identifier: NCT00875953     History of Changes
Other Study ID Numbers: UCENT003
Study First Received: April 3, 2009
Last Updated: December 13, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Calgary:
squamous cell carcinoma
head and neck cancer
neck dissection

ClinicalTrials.gov processed this record on May 19, 2013