The Efficacy and Safety of Thunderbeat in Thyroid Surgery

Not Applicable

Completed

• Conditions: Thyroid
• Interventions: Device: Thunderbeat (Group A); Device: Harmonic (Group B)

• Registration Number: NCT02304172
• Lead Sponsor: Seoul National University Hospital

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 Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-20
• Study First Submitted QC: 2014-11-25
• Study First Posted: 2014-12-01
• Primary Completion: 2015-12
• Status Verified: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-02-12
• Last Update Posted: 2016-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• thyroidectomy
• normal vocal cord

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thunderbeat (Group A)	Thunderbeat (Group A)	Patients submitted to thyroidectomy with the use of the Thunderbeat device.
Harmonic (Group B)	Harmonic (Group B)	Patients submitted to thyroidectomy with the use of the Harmonic scalpel device

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Hemostasis	intraoperatively (from skin incision to skin closure) & postoperatively (from skin closure until 2 day postoperatively)
Operative time	from skin incision to skin closure

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of