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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)

Primary Purpose

Oral Cavity Squamous Cell Carcinoma, Treated With Surgery

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
surgical resection
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Cavity Squamous Cell Carcinoma, Treated With Surgery focused on measuring oral cavity squamous cell carcinoma, head and neck cancer, oral cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age > 18 years
  • oral cavity scc
  • primary surgery including either uni or bilateral neck dissection (levels I-IV)

Exclusion Criteria:

  • previous treatment for head and neck cancer
  • unable or unwilling to give informed consent
  • history of bleeding disorder
  • other contraindications to surgery

Sites / Locations

  • Foothills Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

harmonic scalpel

standard technique

Arm Description

Outcomes

Primary Outcome Measures

blood loss

Secondary Outcome Measures

operating time

Full Information

First Posted
January 31, 2012
Last Updated
December 1, 2014
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT02017834
Brief Title
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?
Acronym
HS2
Official Title
Does the Harmonic Scalpel Reduce Operating Time and Blood Loss in Patients Undergoing Major Surgery for Oral Cavity Squamous Cell Carcinoma? A Prospective, Randomized Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cavity Squamous Cell Carcinoma, Treated With Surgery
Keywords
oral cavity squamous cell carcinoma, head and neck cancer, oral cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
harmonic scalpel
Arm Type
Experimental
Arm Title
standard technique
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
surgical resection
Other Intervention Name(s)
Harmonic Focus handpiece
Intervention Description
neck dissection and tumour resection will be performed either with or without the harmonic scalpel as an adjunct.
Primary Outcome Measure Information:
Title
blood loss
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
operating time
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age > 18 years oral cavity scc primary surgery including either uni or bilateral neck dissection (levels I-IV) Exclusion Criteria: previous treatment for head and neck cancer unable or unwilling to give informed consent history of bleeding disorder other contraindications to surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Dort, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
27821144
Citation
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.
Results Reference
derived

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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?

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