The Efficacy and Safety of Thunderbeat in Thyroid Surgery
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About
The aim of this study is to compare the results of total thyroidectomy using the Thunderbeat device to that with the harmonic scalpel.
Full 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).
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
50 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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