Goiter
Conditions
Keywords
thyroidectomy, ultrasonic dissector, harmonic focus device, superior laryngeal nerve
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.
Interventions
DEVICEThyroidectomy using harmonic focus (r)
Harmonic focus(r) device is used to seal and cut the vessels during thyroidectomy.
PROCEDUREConventional thyroidectomy
Vessels are ligated with sutures then cut using classic scalpel or scissors.
Sponsors
S.B. Konya Education and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assessment of hemorrhage | 3 day | Amounts of peroperative and postoperative hemorrhage will be recorded |
Countries
Turkey (Türkiye)
Contacts
Primary ContactOsman DOĞRU, M.D.
Outcome results
None listed