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Randomized Controlled Trial of Bipolar Versus Ultrasonic Hemostasis Techniques in Thyroidectomy

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00524966
First received: September 4, 2007
Last updated: July 7, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention
Head and Neck Cancer
 Procedure: Bipolar Versus Ultrasonic Hemostasis Techniques

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Bipolar Versus Ultrasonic Hemostasis Techniques in Thyroidectomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Blood loss and hypocalcemia [ Time Frame: one week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost of thyroidectomy [ Time Frame: one week ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00524966

Locations
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
Principal Investigator: Electron Kebebew, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Electron Kebebew, MD, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00524966     History of Changes
Other Study ID Numbers: Harmonic
Study First Received: September 4, 2007
Last Updated: July 7, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Hemostatics
 Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013