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

Study Overview
=================
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.

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

Conditions
-----------------
Goiter

Intervention / Treatment
-----------------
* Device: Thyroidectomy using harmonic focus (r)
* Procedure: Conventional thyroidectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasonic Dissector Thyroidectomy<br>Thyroidectomy using harmonic focus (r) device | Device: Thyroidectomy using harmonic focus (r)<br>* Harmonic focus(r) device is used to seal and cut the vessels during thyroidectomy.<br>* Other names: Ethicon(r) Harmonic Focus(r) Curved Shears;|
| Active Comparator: Classic thyroidectomy<br>Patients having conventional thyroidectomy | Procedure: Conventional thyroidectomy<br>* Vessels are ligated with sutures then cut using classic scalpel or scissors.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of superior laryngeal nerve function | Patients will be checked for superior laryngeal nerve function by laryngostroboscopy one day after thyroidectomy and 6 months after thyroidectomy. | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thyroidectomy, ultrasonic dissector, harmonic focus device, superior laryngeal nerve