Randomized Controlled Trial of Bipolar Versus Ultrasonic Hemostasis Techniques in Thyroidectomy

NCT ID: NCT00524966

Last Updated: 2011-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-08-31

Brief Summary

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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

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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.

Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Harmonic LigaSure

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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University of California, San Francisco

Principal Investigators

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Electron Kebebew, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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UCSF Comprehensive Cancer Center

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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Harmonic

Identifier Type: -

Identifier Source: org_study_id

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