Energy Device Study in Transoral Endoscopic Thyroidectomy

  • STATUS
    Recruiting
  • End date
    Feb 28, 2023
  • participants needed
    40
  • sponsor
    Inha University Hospital
Updated on 9 March 2022
metastasis

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.

Details
Condition Thyroid Nodule, Thyroid Cancer
Treatment LIGASURE, Harmonic
Clinical Study IdentifierNCT04320901
SponsorInha University Hospital
Last Modified on9 March 2022

Eligibility

Yes No Not Sure

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
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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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