Energy Device Study in Transoral Endoscopic Thyroidectomy

Last updated: February 17, 2022
Sponsor: Inha University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Thyroid Cancer

Thyroid Disease

Treatment

N/A

Clinical Study ID

NCT04320901
2020-01-033
  • Ages 20-70
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

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, myocardialinfarction, 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

Study Design

Total Participants: 40
Study Start date:
April 01, 2020
Estimated Completion Date:
February 28, 2023

Study 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.

Connect with a study center

  • Inha University Hospital

    Incheon, 22332
    Korea, Republic of

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.