Energy Device Study in Transoral Endoscopic Thyroidectomy

February 17, 2022 updated by: Jin Wook Yi, Inha University Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Harmonic
Endoscopic procedure will be done by Harmonic ACE7+
Device: Harmonic
Harmonic ACE 7+
EXPERIMENTAL: Ligasure
Endoscopic procedure will be done by Ligasure
Device: Ligasure
Ligasure™ Maryland Jaw Laparoscopic Sealer/Divider 37cm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operation time
Time Frame: During the procedure
Surgery time during the thyroid lobectomy
During the procedure
Camera cleaning frequency
Time Frame: During the procedure
Numbers of camera cleaning during the lobectomy
During the procedure
Blood loss
Time Frame: During the procedure
Estimated blood loss during the lobectomy
During the procedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inha University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

February 28, 2023

Study Registration Dates

First Submitted

March 20, 2020

First Submitted That Met QC Criteria

March 23, 2020

First Posted (ACTUAL)

March 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 21, 2022

Last Update Submitted That Met QC Criteria

February 17, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-01-033

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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