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Randomized Controlled Trial of Bipolar Versus Ultrasonic Hemostasis Techniques in Thyroidectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00524966
Recruitment Status : Completed
First Posted : September 5, 2007
Last Update Posted : July 11, 2011
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Procedure: Bipolar Versus Ultrasonic Hemostasis Techniques Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Bipolar Versus Ultrasonic Hemostasis Techniques in Thyroidectomy
Study Start Date : August 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Intervention Details:
  • Procedure: Bipolar Versus Ultrasonic Hemostasis Techniques
    OUTLINE: Patients undergoing thyroidectomy for thyroid cancer, thyroid nodules, hyperthyroidism and goiter will be randomized to either bipolar energy sealing system or ultrasonic coagulation.
    Other Names:
    • Harmonic
    • LigaSure


Primary Outcome Measures :
  1. Blood loss and hypocalcemia [ Time Frame: one week ]

Secondary Outcome Measures :
  1. Cost of thyroidectomy [ Time Frame: one week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT00524966


Locations
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United States, California
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Electron Kebebew, MD University of California, San Francisco
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Responsible Party: Electron Kebebew, MD, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00524966    
Other Study ID Numbers: Harmonic
First Posted: September 5, 2007    Key Record Dates
Last Update Posted: July 11, 2011
Last Verified: July 2011
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Hemostatics
Coagulants