The Efficacy and Safety of Thunderbeat in Thyroid Surgery

Study Overview
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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.

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).

Official Title
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The Efficacy and Safety of Thunderbeat in Thyroid Surgery: a Prospective Randomized Study

Conditions
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Thyroid

Intervention / Treatment
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* Device: Thunderbeat (Group A)
* Device: Harmonic (Group B)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thunderbeat (Group A)<br>Patients submitted to thyroidectomy with the use of the Thunderbeat device. | Device: Thunderbeat (Group A)<br>* hemostatic device utilized intraoperatively<br>|
| Active Comparator: Harmonic (Group B)<br>Patients submitted to thyroidectomy with the use of the Harmonic scalpel device | Device: Harmonic (Group B)<br>* hemostatic device utilized intraoperatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn |  | postoperatively (from the day of surgery until 3 months postoperatively) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostasis |  | intraoperatively (from skin incision to skin closure) & postoperatively (from skin closure until 2 day postoperatively) | 
| Operative time |  | from skin incision to skin closure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thyroidectomy, Thunderbeat