Clinical trial NCT01812395: Thyroidectomy Using Ultrasonic Dissector: Is Superior Laryngeal Nerve Really Safe ?
Official title: Is Superior Laryngeal Nerve Really Safe During Thyroidectomy Using Ultrasonic Dissector.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Goiter
Keywords: thyroidectomy
ultrasonic dissector
harmonic focus device
superior laryngeal nerve
Lead sponsor: S.B. Konya Education and Research Hospital
Sponsor class: OTHER
First posted: 2013-03-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Assessment of superior laryngeal nerve function
timeFrame: 6 months
Secondary outcomes:
measure: Assessment of inferior laryngeal nerve function
timeFrame: 6 months
measure: Assessment of other complications
timeFrame: 1 week
Other outcomes:
measure: Assessment of hemorrhage
timeFrame: 3 day
Locations:
city: Meram
country: Turkey
facility: Konya Education and Research Hospital
state: Konya
Study officials:
affiliation: Konya Education and Research Hospital General Surgery Clinic
name: Osman DOĞRU, M.D.
role: STUDY_DIRECTOR
References:
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