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

Not Applicable

• Conditions: Goiter
• Interventions: Procedure: Conventional thyroidectomy; Device: Thyroidectomy using harmonic focus (r)

• Registration Number: NCT01812395
• Lead Sponsor: S.B. Konya Education and Research Hospital

Brief 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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-08
• Study First Submitted QC: 2013-03-13
• Study First Posted: 2013-03-18
• Status Verified: 2014-03
• Primary Completion: 2014-03
• Last Update Submitted: 2014-03-21
• Last Update Posted: 2014-03-24
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients having thyroidectomy

Exclusion Criteria

• Previous neck surgery
• Thyroid cancers
• History of superior or inferior laryngeal nerve paralysis
• History of neck irradiation
• Pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Classic thyroidectomy	Conventional thyroidectomy	Patients having conventional thyroidectomy
Ultrasonic Dissector Thyroidectomy	Thyroidectomy using harmonic focus (r)	Thyroidectomy using harmonic focus (r) device

Primary Outcome Measures

Name	Time	Method
Assessment of superior laryngeal nerve function	6 months	Patients will be checked for superior laryngeal nerve function by laryngostroboscopy one day after thyroidectomy and 6 months after thyroidectomy.

Secondary Outcome Measures

Name	Time	Method
Assessment of inferior laryngeal nerve function	6 months	Patients will be checked for inferior laryngeal nerve function by laryngostroboscopy one day after thyroidectomy and 6 months after thyroidectomy.
Assessment of other complications	1 week	Whether patients develop postoperative seroma, haematoma, infection or maceration will be recorded

Trial Locations

Locations (1)

Konya Education and Research Hospital; 🇹🇷 Meram, Konya, Turkey