Use of the Harmonic Scalpel in Neck Dissection
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|ClinicalTrials.gov Identifier: NCT00875953|
Recruitment Status : Completed
First Posted : April 6, 2009
Last Update Posted : December 14, 2010
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 or disease||Intervention/treatment||Phase|
|Neck Dissection||Procedure: standard neck dissection Procedure: Harmonic Scalpel Dissection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Harmonic Scalpel vs. Electrocautery in Modified Radical Neck Dissection: A Single Blinded Prospective Randomized Trial|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||December 2010|
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
- operative blood loss [ Time Frame: intraoperative ]
- Operating Time [ Time Frame: at end of the procedure ]
- wound drainage [ Time Frame: 48 hours ]
- wound infection [ Time Frame: 48 hours, 1 week ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00875953
|Foothills Medical Centre|
|Calgary, Alberta, Canada, T2N 4N1|
|Principal Investigator:||Joseph C Dort, BSc, MSc, MD||University of Calgary - Faculty of Medicine|