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Energy Device Study in Transoral Endoscopic Thyroidectomy

Primary Purpose

Thyroid Nodule, Thyroid Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ligasure
Harmonic
Sponsored by
Inha University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Nodule

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who planned to transoral endoscopic thyroidectomy
  • Age between 20 to 70
  • Voluntarily consenting to the study and study agreement
  • No local invasion or distant metastasis
  • Normal vocal cord function in laryngoscopic exam
  • No significant abnormalities in preoperative laboratory tests

Exclusion Criteria:

  • Take aspirin or antiplatelet drugs within 7 days before admission
  • Uncontrolled hypertension, diabetes, chronic renal failure, or coagulation disease
  • History of cardiovascular disease (angina pectoris, heart failure, myocardial infarction, history of coronary artery disease, stroke, transient ischemic attack)
  • Substance abuse and alcohol abuse
  • History of esophageal and airway diseases
  • Patient was participated in other clinical trials within 30 days
  • History of neck irradiation or surgery
  • History of severe drug allergies
  • Pregnant or lactating women

Sites / Locations

  • Inha University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Harmonic

Ligasure

Arm Description

Endoscopic procedure will be done by Harmonic ACE7+

Endoscopic procedure will be done by Ligasure

Outcomes

Primary Outcome Measures

Operation time
Surgery time during the thyroid lobectomy
Camera cleaning frequency
Numbers of camera cleaning during the lobectomy
Blood loss
Estimated blood loss during the lobectomy

Secondary Outcome Measures

Pain score
visual analogue scale, ranged from 0-10 (0: no pain, 10: maximal pain)
Drain amount
24-hour drain amount (ml/day)

Full Information

First Posted
March 20, 2020
Last Updated
February 17, 2022
Sponsor
Inha University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04320901
Brief Title
Energy Device Study in Transoral Endoscopic Thyroidectomy
Official Title
Comparative Analysis Between Harmonic Versus LigaSure in Transoral Endoscopic Thyroidectomy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inha University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Open label randomized controlled study, for Harmonic versus Ligasure in transoral endoscopic thyroid surgery.
Detailed Description
This is a prospective randomized controlled study. The principal investigator or another clinical investigator in charge will individually inform the patients about the study, on the day before surgery. When informed consent is obtained, an investigator in charge of randomization only, will randomize the patients. According to randomization, the experimental group will Ligasure and the control group will use Harmonic ACE 7+. Other than the randomized use of energy devices, the protocol for TOETVA is performed as usual. Operation time (from insertion of the laparoscopic camera to removal of the camera), number of times the camera was cleaned, intraoperative blood loss will recorded. Postoperative hospital stay, visual analog pain scale, blood cell count and inflammatory parameters, postoperative drain amount will recorded. Complications of thyroid surgery (vocal cord dysfunction, hypoparathyroidism) are compared for safety assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodule, Thyroid Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Harmonic
Arm Type
Experimental
Arm Description
Endoscopic procedure will be done by Harmonic ACE7+
Arm Title
Ligasure
Arm Type
Experimental
Arm Description
Endoscopic procedure will be done by Ligasure
Intervention Type
Device
Intervention Name(s)
Ligasure
Intervention Description
Ligasure™ Maryland Jaw Laparoscopic Sealer/Divider 37cm
Intervention Type
Device
Intervention Name(s)
Harmonic
Intervention Description
Harmonic ACE 7+
Primary Outcome Measure Information:
Title
Operation time
Description
Surgery time during the thyroid lobectomy
Time Frame
During the procedure
Title
Camera cleaning frequency
Description
Numbers of camera cleaning during the lobectomy
Time Frame
During the procedure
Title
Blood loss
Description
Estimated blood loss during the lobectomy
Time Frame
During the procedure
Secondary Outcome Measure Information:
Title
Pain score
Description
visual analogue scale, ranged from 0-10 (0: no pain, 10: maximal pain)
Time Frame
Postoperative 1st and 2nd days
Title
Drain amount
Description
24-hour drain amount (ml/day)
Time Frame
Postoperative 1st and 2nd days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who planned to transoral endoscopic thyroidectomy Age between 20 to 70 Voluntarily consenting to the study and study agreement No local invasion or distant metastasis Normal vocal cord function in laryngoscopic exam No significant abnormalities in preoperative laboratory tests Exclusion Criteria: Take aspirin or antiplatelet drugs within 7 days before admission Uncontrolled hypertension, diabetes, chronic renal failure, or coagulation disease History of cardiovascular disease (angina pectoris, heart failure, myocardial infarction, history of coronary artery disease, stroke, transient ischemic attack) Substance abuse and alcohol abuse History of esophageal and airway diseases Patient was participated in other clinical trials within 30 days History of neck irradiation or surgery History of severe drug allergies Pregnant or lactating women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Wook Yi, Professor
Phone
+82-32-890-3437
Email
jinwook.yi@inha.ac.kr
Facility Information:
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Wook Yi, Dr.
Phone
+82-32-890-3437
Email
jinwook.yi@inha.ac.kr

12. IPD Sharing Statement

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Energy Device Study in Transoral Endoscopic Thyroidectomy

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