Open label randomized controlled study, for Harmonic versus Ligasure in transoral endoscopic thyroid surgery.
* 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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Inha University Hospital
Incheon, South Korea
RECRUITINGOperation time
Surgery time during the thyroid lobectomy
Time frame: During the procedure
Camera cleaning frequency
Numbers of camera cleaning during the lobectomy
Time frame: During the procedure
Blood loss
Estimated blood loss during the lobectomy
Time frame: During the procedure
Pain score
visual analogue scale, ranged from 0-10 (0: no pain, 10: maximal pain)
Time frame: Postoperative 1st and 2nd days
Drain amount
24-hour drain amount (ml/day)
Time frame: Postoperative 1st and 2nd days
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