The Efficacy and Safety of Thunderbeat in Thyroid Surgery (Thunderbeat)

February 12, 2016 updated by: Su-jin Kim, Seoul National University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Thunderbeat (Group A)
Patients submitted to thyroidectomy with the use of the Thunderbeat device.
Device: Thunderbeat (Group A)
hemostatic device utilized intraoperatively
Active Comparator: Harmonic (Group B)
Patients submitted to thyroidectomy with the use of the Harmonic scalpel device
Device: Harmonic (Group B)
hemostatic device utilized intraoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
postoperatively (from the day of surgery until 3 months postoperatively)

Secondary Outcome Measures

Outcome Measure
Time Frame
Operative time
Time Frame: from skin incision to skin closure
from skin incision to skin closure
Hemostasis
Time Frame: intraoperatively (from skin incision to skin closure) & postoperatively (from skin closure until 2 day postoperatively)
intraoperatively (from skin incision to skin closure) & postoperatively (from skin closure until 2 day postoperatively)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Olympus Korea Co., Ltd.

Investigators

  • Principal Investigator: Su-jin Kim, MD, PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

November 20, 2014

First Submitted That Met QC Criteria

November 25, 2014

First Posted (Estimate)

December 1, 2014

Study Record Updates

Last Update Posted (Estimate)

February 15, 2016

Last Update Submitted That Met QC Criteria

February 12, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUHthyroid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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