The Efficacy and Safety of Thunderbeat in Thyroid Surgery

Thyroid Clinical Trial

— Thunderbeat  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02304172
• Other study ID #: SNUHthyroid
• Status: Completed
• Phase: N/A
• First received: November 20, 2014
• Last updated: February 12, 2016
• Start date: November 2014
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the results of total thyroidectomy using the Thunderbeat device to that with the harmonic scalpel.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thyroid
• Thyroid Diseases

Intervention

Device:
• Thunderbeat (Group A)
hemostatic device utilized intraoperatively
• Harmonic (Group B)
hemostatic device utilized intraoperatively

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Olympus Korea Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn		postoperatively (from the day of surgery until 3 months postoperatively)	Yes
Secondary	Hemostasis		intraoperatively (from skin incision to skin closure) & postoperatively (from skin closure until 2 day postoperatively)	Yes
Secondary	Operative time		from skin incision to skin closure	Yes