Thyroid Nodule, Thyroid Cancer
Conditions
Brief summary
Open label randomized controlled study, for Harmonic versus Ligasure in transoral endoscopic thyroid surgery.
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.
Interventions
Sponsors
Inha University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operation time | During the procedure | Surgery time during the thyroid lobectomy |
| Camera cleaning frequency | During the procedure | Numbers of camera cleaning during the lobectomy |
| Blood loss | During the procedure | Estimated blood loss during the lobectomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain score | Postoperative 1st and 2nd days | visual analogue scale, ranged from 0-10 (0: no pain, 10: maximal pain) |
| Drain amount | Postoperative 1st and 2nd days | 24-hour drain amount (ml/day) |
Countries
South Korea
Contacts
Primary ContactJin Wook Yi, Professor
Outcome results
None listed