Back to resultsThe Efficacy and Safety of Thunderbeat in Thyroid Surgery (Thunderbeat)
Primary Purpose
Thyroid
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Thunderbeat (Group A)
Harmonic (Group B)
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid focused on measuring Thyroidectomy, Thunderbeat
Eligibility Criteria
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Thunderbeat (Group A)
Harmonic (Group B)
Arm Description
Patients submitted to thyroidectomy with the use of the Thunderbeat device.
Patients submitted to thyroidectomy with the use of the Harmonic scalpel device
Outcomes
Primary Outcome Measures
Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn
Secondary Outcome Measures
Hemostasis
Operative time
Full Information
NCT ID
NCT02304172
First Posted
November 20, 2014
Last Updated
February 12, 2016
Sponsor
Seoul National University Hospital
Collaborators
Olympus Korea Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02304172
Brief Title
The Efficacy and Safety of Thunderbeat in Thyroid Surgery
Acronym
Thunderbeat
Official Title
The Efficacy and Safety of Thunderbeat in Thyroid Surgery: a Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Olympus Korea Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid
Keywords
Thyroidectomy, Thunderbeat
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thunderbeat (Group A)
Arm Type
Active Comparator
Arm Description
Patients submitted to thyroidectomy with the use of the Thunderbeat device.
Arm Title
Harmonic (Group B)
Arm Type
Active Comparator
Arm Description
Patients submitted to thyroidectomy with the use of the Harmonic scalpel device
Intervention Type
Device
Intervention Name(s)
Thunderbeat (Group A)
Intervention Description
hemostatic device utilized intraoperatively
Intervention Type
Device
Intervention Name(s)
Harmonic (Group B)
Intervention Description
hemostatic device utilized intraoperatively
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Hemostasis
Time Frame
intraoperatively (from skin incision to skin closure) & postoperatively (from skin closure until 2 day postoperatively)
Title
Operative time
Time Frame
from skin incision to skin closure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Su-jin Kim, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Efficacy and Safety of Thunderbeat in Thyroid Surgery
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