Energy Device Study in Transoral Endoscopic Thyroidectomy

Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04320901
• Other study ID #: 2020-01-033
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: February 28, 2023

Study information

• Verified date: February 2022
• Source: Inha University Hospital
• Contact: Jin Wook Yi, Professor
• Phone: +82-32-890-3437
• Email: jinwook.yi[@]inha.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Open label randomized controlled study, for Harmonic versus Ligasure in transoral endoscopic thyroid surgery.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 28, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms
• Thyroid Nodule

Intervention

Device:
• Ligasure
Ligasure™ Maryland Jaw Laparoscopic Sealer/Divider 37cm
• Harmonic
Harmonic ACE 7+

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Inha University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operation time	Surgery time during the thyroid lobectomy	During the procedure
Primary	Camera cleaning frequency	Numbers of camera cleaning during the lobectomy	During the procedure
Primary	Blood loss	Estimated blood loss during the lobectomy	During the procedure
Secondary	Pain score	visual analogue scale, ranged from 0-10 (0: no pain, 10: maximal pain)	Postoperative 1st and 2nd days
Secondary	Drain amount	24-hour drain amount (ml/day)	Postoperative 1st and 2nd days