Energy Device Study in Transoral Endoscopic Thyroidectomy
NCT ID: NCT04320901
Last Updated: 2022-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2020-04-01
2023-02-28
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Harmonic
Endoscopic procedure will be done by Harmonic ACE7+
Harmonic
Harmonic ACE 7+
Ligasure
Endoscopic procedure will be done by Ligasure
Ligasure
Ligasure™ Maryland Jaw Laparoscopic Sealer/Divider 37cm
Interventions
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Ligasure
Ligasure™ Maryland Jaw Laparoscopic Sealer/Divider 37cm
Harmonic
Harmonic ACE 7+
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
70 Years
ALL
No
Sponsors
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Inha University Hospital
OTHER
Responsible Party
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Jin Wook Yi
Assistant Professor
Locations
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Inha University Hospital
Incheon, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2020-01-033
Identifier Type: -
Identifier Source: org_study_id
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