Randomized Controlled Trial of Bipolar Versus Ultrasonic Hemostasis Techniques in Thyroidectomy

Not Applicable

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT00524966
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-09-04
• Study First Submitted QC: 2007-09-04
• Study First Posted: 2007-09-05
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-07
• Last Update Posted: 2011-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Blood loss and hypocalcemia	one week

Secondary Outcome Measures

Name	Time	Method
Cost of thyroidectomy	one week

Trial Locations

Locations (1)

UCSF Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States