NCT02304172

The Efficacy and Safety of Thunderbeat in Thyroid Surgery

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

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).

Conditions

• Thyroid

Interventions

Type	Name	Description
DEVICE	Thunderbeat (Group A)	hemostatic device utilized intraoperatively
DEVICE	Harmonic (Group B)	hemostatic device utilized intraoperatively

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-12-01
• Completion: 2016-02-01
• First posted: 2014-12-01
• Last updated: 2016-02-15

Locations

1 site across 1 country: South Korea