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

S.B. Konya Education and Research Hospital

Status: Unknown

Conditions: Goiter

Treatments: Procedure: Conventional thyroidectomy; Device: Thyroidectomy using harmonic focus (r)

Study type: Interventional

Funder types: Other

Identifiers

NCT01812395

KEAH07031301

U1111-1140-3809 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Ultrasonic Dissector Thyroidectomy

Active Comparator group

Description:

Thyroidectomy using harmonic focus (r) device

Treatment:

Device: Thyroidectomy using harmonic focus (r)

Classic thyroidectomy

Active Comparator group

Description:

Patients having conventional thyroidectomy

Treatment:

Procedure: Conventional thyroidectomy