Back to resultsRandomized Controlled Trial of Bipolar Versus Ultrasonic Hemostasis Techniques in Thyroidectomy
Primary Purpose
Head and Neck Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bipolar Versus Ultrasonic Hemostasis Techniques
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients requiring thyroidectomy
Exclusion Criteria:
- Patients unwilling or unable to provide informed consent
- Age less than 18 years old
- Reoperative case
- Patients who use pacemakers
Sites / Locations
- UCSF Comprehensive Cancer Center
Outcomes
Primary Outcome Measures
Blood loss and hypocalcemia
Secondary Outcome Measures
Cost of thyroidectomy
Full Information
NCT ID
NCT00524966
First Posted
September 4, 2007
Last Updated
July 7, 2011
Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00524966
Brief Title
Randomized Controlled Trial of Bipolar Versus Ultrasonic Hemostasis Techniques in Thyroidectomy
Official Title
Randomized Controlled Trial of Bipolar Versus Ultrasonic Hemostasis Techniques in Thyroidectomy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
RATIONALE: The use of bipolar energy sealing system or ultrasonic coagulation for hemostasis during thyroidectomy may reduce blood loss and hypocalcemia and may be more cost-effective.
Detailed Description
PURPOSE: This clinical trial is studying how well bipolar energy sealing system and ultrasonic coagulation for hemostasis during thyroidectomy reduce blood loss and hypocalcemia, as well as which device is the most cost-effective approach for thyroidectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Bipolar Versus Ultrasonic Hemostasis Techniques
Other Intervention Name(s)
Harmonic, LigaSure
Intervention Description
OUTLINE: Patients undergoing thyroidectomy for thyroid cancer, thyroid nodules, hyperthyroidism and goiter will be randomized to either bipolar energy sealing system or ultrasonic coagulation.
Primary Outcome Measure Information:
Title
Blood loss and hypocalcemia
Time Frame
one week
Secondary Outcome Measure Information:
Title
Cost of thyroidectomy
Time Frame
one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients requiring thyroidectomy
Exclusion Criteria:
Patients unwilling or unable to provide informed consent
Age less than 18 years old
Reoperative case
Patients who use pacemakers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Electron Kebebew, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Randomized Controlled Trial of Bipolar Versus Ultrasonic Hemostasis Techniques in Thyroidectomy
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