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| Name | Class |
|---|---|
| Olympus Korea Co., Ltd. | UNKNOWN |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thunderbeat (Group A) | Active Comparator | Patients submitted to thyroidectomy with the use of the Thunderbeat device. |
|
| Harmonic (Group B) | Active Comparator | Patients submitted to thyroidectomy with the use of the Harmonic scalpel device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thunderbeat (Group A) | Device | hemostatic device utilized intraoperatively |
| |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Su-jin Kim, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
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| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
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| Harmonic (Group B) |
| Device |
hemostatic device utilized intraoperatively |
|