Energy Device Study in Transoral Endoscopic Thyroidectomy

Not Applicable

• Conditions: Thyroid Nodule; Thyroid Cancer
• Interventions: Device: Harmonic; Device: Ligasure

• Registration Number: NCT04320901
• Lead Sponsor: Inha University Hospital

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 Timeline

• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-25
• Study Start: 2020-04-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-17
• Last Update Posted: 2022-02-21
• Primary Completion: 2022-12-31
• Study Completion: 2023-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Harmonic	Harmonic	Endoscopic procedure will be done by Harmonic ACE7+
Ligasure	Ligasure	Endoscopic procedure will be done by Ligasure

Primary Outcome Measures

Name	Time	Method
Camera cleaning frequency	During the procedure	Numbers of camera cleaning during the lobectomy
Blood loss	During the procedure	Estimated blood loss during the lobectomy
Operation time	During the procedure	Surgery time during the thyroid lobectomy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of