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Completed

NCT Number: NCT00524966

Randomized Controlled Trial of Bipolar Versus Ultrasonic Hemostasis Techniques in Thyroidectomy

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bipolar Versus Ultrasonic Hemostasis Techniques

Procedure

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 outcomes

  1. Blood loss and hypocalcemia

    Time frame: one week

Secondary outcomes

  1. Cost of thyroidectomy

    Time frame: one week

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 5, 2007
Registry last updated
Jul 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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