Thyroid
Conditions
Keywords
Thyroidectomy, Thunderbeat
Brief summary
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
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).
Interventions
DEVICEThunderbeat (Group A)
hemostatic device utilized intraoperatively
DEVICEHarmonic (Group B)
hemostatic device utilized intraoperatively
Sponsors
Olympus Korea Co., Ltd.
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
South Korea
Outcome results
None listed