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Randomized Controlled Trial of Bipolar Versus Ultrasonic Hemostasis Techniques in Thyroidectomy

Randomized Controlled Trial of Bipolar Versus Ultrasonic Hemostasis Techniques in Thyroidectomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00524966
Enrollment
100
Registered
2007-09-05
Start date
2007-08-31
Completion date
2009-08-31
Last updated
2011-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

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.

Interventions

PROCEDUREBipolar 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.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Blood loss and hypocalcemiaone week

Secondary

MeasureTime frame
Cost of thyroidectomyone week

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026