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Completed

NCT Number: NCT02304172

The Efficacy and Safety of Thunderbeat in Thyroid Surgery

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

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Key information

Conditions

Thyroid Endocrine System Diseases Thyroid Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thunderbeat (Group A)

Device

hemostatic device utilized intraoperatively

Harmonic (Group B)

Device

hemostatic device utilized intraoperatively

Primary outcomes

  1. 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

  1. Hemostasis

    Time frame: intraoperatively (from skin incision to skin closure) & postoperatively (from skin closure until 2 day postoperatively)

  2. Operative time

    Time frame: from skin incision to skin closure

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Olympus Korea Co., Ltd.

Registry information

Official study title

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

Acronym: Thunderbeat

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Dec 1, 2014
Registry last updated
Feb 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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