Energy Device Study in Transoral Endoscopic Thyroidectomy

Study Overview
=================
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.

Official Title
-----------------
Comparative Analysis Between Harmonic Versus LigaSure in Transoral Endoscopic Thyroidectomy: A Randomized Controlled Trial

Conditions
-----------------
Thyroid Nodule, Thyroid Cancer

Intervention / Treatment
-----------------
* Device: Ligasure
* Device: Harmonic


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Harmonic<br>Endoscopic procedure will be done by Harmonic ACE7+ | Device: Harmonic<br>* Harmonic ACE 7+<br>|
| Experimental: Ligasure<br>Endoscopic procedure will be done by Ligasure | Device: Ligasure<br>* Ligasure™ Maryland Jaw Laparoscopic Sealer/Divider 37cm<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | Surgery time during the thyroid lobectomy | During the procedure | 
| Camera cleaning frequency | Numbers of camera cleaning during the lobectomy | During the procedure | 
| Blood loss | Estimated blood loss during the lobectomy | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | visual analogue scale, ranged from 0-10 (0: no pain, 10: maximal pain) | Postoperative 1st and 2nd days | 
| Drain amount | 24-hour drain amount (ml/day) | Postoperative 1st and 2nd days |