The Efficacy and Safety of Thunderbeat in Thyroid Surgery

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-02-29

Brief Summary

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The aim of this study is to compare the results of total thyroidectomy using the Thunderbeat device to that with the harmonic scalpel.

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Detailed Description

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Thunderbeat instrument combines an advanced bipolar clamp to the existing ultrasonic cutter. In the animal study with pig, the result of Thunderbeat shows fast abalation rate and same thermal conductivity. There has been reported a significant reduction in operative time and same complications with Thunderbeat in gynecology patient who underwent laparoscopic hysterectomy with lymph node dissection. Comparison of the utilization of this new device, however, with the Harmonic scalpel in thyroidectomy has not been performed in any study. The objective of this study is to compare the results of thyroidectomy using the Thunderbeat to that with the Harmonic scalpel device in respect to hemostasis, operative time and perioperative complications. All patients undergoing a thyroidectomy in our endocrine surgery department are randomized into those operated with Thunderbeat (Group A) and those with Harmonic scalpel (Group B).

Conditions

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Thyroid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Thunderbeat (Group A)

Patients submitted to thyroidectomy with the use of the Thunderbeat device.

Group Type ACTIVE_COMPARATOR

Thunderbeat (Group A)

Intervention Type DEVICE

hemostatic device utilized intraoperatively

Harmonic (Group B)

Patients submitted to thyroidectomy with the use of the Harmonic scalpel device

Group Type ACTIVE_COMPARATOR

Harmonic (Group B)

Intervention Type DEVICE

hemostatic device utilized intraoperatively

Interventions

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Thunderbeat (Group A)

hemostatic device utilized intraoperatively

Intervention Type DEVICE

Harmonic (Group B)

hemostatic device utilized intraoperatively

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* thyroidectomy
* normal vocal cord

Exclusion Criteria

* additional surgical procedures together with the total thyroidectomy (i.e., parathyroidectomy or cervical lymph node dissection)
* Thyroid cancer patients with lymph node metastasis
* pregnant women
* uncontrolled hypertension, DM, chronic kidney failure, coagulation disorders
* aspirin or anti-platelet agent in 7 days
* Graves' disease or Hashimoto thyroiditis
* history of radiation treatment in head and neck area

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes