The Efficacy and Safety of Thunderbeat in Thyroid Surgery: a Prospective Randomized Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Thunderbeat (Group A)
Patients submitted to thyroidectomy with the use of the Thunderbeat device.
Intervention: Thunderbeat (Group A) (Device)
Harmonic (Group B)
Patients submitted to thyroidectomy with the use of the Harmonic scalpel device
Intervention: Harmonic (Group B) (Device)
Outcomes
Primary Outcomes
Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn
Time Frame: postoperatively (from the day of surgery until 3 months postoperatively)
Secondary Outcomes
- Hemostasis(intraoperatively (from skin incision to skin closure) & postoperatively (from skin closure until 2 day postoperatively))
- Operative time(from skin incision to skin closure)
Investigators
Su-jin Kim
Clinical Assistant Professor
Seoul National University Hospital