Energy Device Study in Transoral Endoscopic Thyroidectomy
Comparative Analysis Between Harmonic Versus LigaSure in Transoral Endoscopic Thyroidectomy: A Randomized Controlled Trial
1 other identifier
interventional
40
1 country
1
Brief Summary
Open label randomized controlled study, for Harmonic versus Ligasure in transoral endoscopic thyroid surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2020
CompletedFirst Posted
Study publicly available on registry
March 25, 2020
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedFebruary 21, 2022
February 1, 2022
2.8 years
March 20, 2020
February 17, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Operation time
Surgery time during the thyroid lobectomy
During the procedure
Camera cleaning frequency
Numbers of camera cleaning during the lobectomy
During the procedure
Blood loss
Estimated blood loss during the lobectomy
During the procedure
Secondary Outcomes (2)
Pain score
Postoperative 1st and 2nd days
Drain amount
Postoperative 1st and 2nd days
Study Arms (2)
Harmonic
EXPERIMENTALEndoscopic procedure will be done by Harmonic ACE7+
Ligasure
EXPERIMENTALEndoscopic procedure will be done by Ligasure
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Inha University Hospital
Incheon, 22332, South Korea
Related Publications (1)
Park SY, Shin MH, Hwang YM, Choi YS, Yi JW. Comparative analysis between ultrasonic shears versus advanced bipolar device in transoral endoscopic thyroidectomy: a randomized controlled trial. Gland Surg. 2023 Sep 25;12(9):1191-1202. doi: 10.21037/gs-23-227. Epub 2023 Sep 18.
PMID: 37842523DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 20, 2020
First Posted
March 25, 2020
Study Start
April 1, 2020
Primary Completion
December 31, 2022
Study Completion
February 28, 2023
Last Updated
February 21, 2022
Record last verified: 2022-02