NCT04320901

Energy Device Study in Transoral Endoscopic Thyroidectomy

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Inha University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thyroid Nodule
• Thyroid Cancer

Interventions

Type	Name	Description
DEVICE	Ligasure	Ligasure™ Maryland Jaw Laparoscopic Sealer/Divider 37cm
DEVICE	Harmonic	Harmonic ACE 7+

Timeline

• Start date: 2020-04-01
• Primary completion: 2022-12-31
• Completion: 2023-02-28
• First posted: 2020-03-25
• Last updated: 2022-02-21

Locations

1 site across 1 country: South Korea