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NCT00524966 Clinical Trial

Randomized Controlled Trial of Bipolar Versus Ultrasonic Hemostasis Techniques in Thyroidectomy

Head and Neck Cancer Clinical Trial

Official title:
Randomized Controlled Trial of Bipolar Versus Ultrasonic Hemostasis Techniques in Thyroidectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00524966
Other study ID # Harmonic
Secondary ID
Status Completed
Phase N/A
First received September 4, 2007
Last updated July 7, 2011
Start date August 2007
Est. completion date August 2009

Study information
Verified date July 2011
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States UCSF Comprehensive Cancer Center San Francisco California

Sponsors (2)
Lead Sponsor Collaborator
University of California, San Francisco National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood loss and hypocalcemia one week No
Secondary Cost of thyroidectomy one week No
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