NCT01812395

Thyroidectomy Using Ultrasonic Dissector: Is Superior Laryngeal Nerve Really Safe ?

Is Superior Laryngeal Nerve Really Safe During Thyroidectomy Using Ultrasonic Dissector.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: S.B. Konya Education and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

New devices and techniques are coming into use everyday. Ultrasonic dissectors (UDs) are such new devices which is a practical alternative to the usage of scalpel and sutures. UD's cause overheating of neighboring tissues in an area of 1 to 3 millimeters. Due to the generated heat UDs might cause nerve injury. The investigators would like to see if usage of UDs during thyroidectomy poses a risk for superior laryngeal nerve injury compared to conventional thyroidectomy.

Detailed description

We see new advances in the practice of surgery nearly everyday. New techniques and devices became available and even newer ones are under developement. Ultrasonic Dissectors (UDs) which are primarily developed for laparoscopic surgery found widespread use in thyroid surgery. UDs while closing the nearby vessels cause overheating of neighboring tissues in a 1-3 mm. area. Due to the generated heat UDs might cause nerve injury. We would like to see if usage of UDs during thyroidectomy poses a risk for superior laryngeal nerve injury compared to conventional thyroidectomy where vessels are first sealed with sutures then cut. To this end patients in both conventional and ultrasonic dissector thyroidectomy arms will be checked for superior laryngeal nerve function the day following operation and six months later.

Conditions

• Goiter

Interventions

Type	Name	Description
DEVICE	Thyroidectomy using harmonic focus (r)	Harmonic focus(r) device is used to seal and cut the vessels during thyroidectomy.
PROCEDURE	Conventional thyroidectomy	Vessels are ligated with sutures then cut using classic scalpel or scissors.

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-03-01
• Completion: 2014-04-01
• First posted: 2013-03-18
• Last updated: 2014-03-24

Locations

1 site across 1 country: Turkey (Türkiye)