NCT04320901UnknownNot Applicable
Comparative Analysis Between Harmonic Versus LigaSure in Transoral Endoscopic Thyroidectomy: A Randomized Controlled Trial
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Inha University Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Blood loss
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Harmonic
Experimental
Endoscopic procedure will be done by Harmonic ACE7+
Intervention: Harmonic (Device)
Ligasure
Experimental
Endoscopic procedure will be done by Ligasure
Intervention: Ligasure (Device)
Outcomes
Primary Outcomes
Blood loss
Time Frame: During the procedure
Estimated blood loss during the lobectomy
Camera cleaning frequency
Time Frame: During the procedure
Numbers of camera cleaning during the lobectomy
Operation time
Time Frame: During the procedure
Surgery time during the thyroid lobectomy
Secondary Outcomes
- Drain amount(Postoperative 1st and 2nd days)
- Pain score(Postoperative 1st and 2nd days)
Investigators
Jin Wook Yi
Assistant Professor
Inha University Hospital
Study Sites (1)
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