Does the Harmonic Scalpel Reduce Blood Loss and OR Time in Major Head and Neck Cancer Surgery Undergoing Major Surgery for Oral Cavity Squamous Cell Carcinoma?
HS2
1 other identifier
interventional
36
1 country
1
Brief Summary
The harmonic scalpel is a tool that may reduce operative blood loss. Some studies also indicate it may result in faster surgery. A recently published randomized study from our group shows the harmonic scalpel reduces blood loss in neck dissection but it did not offer any reduction in OR time. The present study investigates the utility of the harmonic scalpel in resections involving removal of oral cavity tissues as well as the neck. Oral cavity resections are especially prone to blood loss and we believe the harmonic scalpel will confer benefits in this type of surgery, potentially reducing the need for blood transfusion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2012
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedFirst Posted
Study publicly available on registry
December 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedDecember 3, 2014
December 1, 2013
2.8 years
January 31, 2012
December 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
blood loss
intraoperative
Secondary Outcomes (1)
operating time
intraoperative
Study Arms (2)
harmonic scalpel
EXPERIMENTALstandard technique
ACTIVE COMPARATORInterventions
neck dissection and tumour resection will be performed either with or without the harmonic scalpel as an adjunct.
Eligibility Criteria
You may qualify if:
- age \> 18 years
- oral cavity scc
- primary surgery including either uni or bilateral neck dissection (levels I-IV)
You may not qualify if:
- previous treatment for head and neck cancer
- unable or unwilling to give informed consent
- history of bleeding disorder
- other contraindications to surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Foothills Hospital
Calgary, Alberta, T2N 4N1, Canada
Related Publications (1)
Fritz DK, Matthews TW, Chandarana SP, Nakoneshny SC, Dort JC. Harmonic scalpel impact on blood loss and operating time in major head and neck surgery: a randomized clinical trial. J Otolaryngol Head Neck Surg. 2016 Nov 8;45(1):58. doi: 10.1186/s40463-016-0173-z.
PMID: 27821144DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Dort, MD
University of Calgary
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ohlson Professor of Head & Neck Surgery
Study Record Dates
First Submitted
January 31, 2012
First Posted
December 23, 2013
Study Start
February 1, 2012
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
December 3, 2014
Record last verified: 2013-12