Carcinoma, Papillary, Follicular
Conditions
Keywords
superior laryngeal nerve
Brief summary
The paralysis of the external branch of superior laryngeal nerves after thyroid surgery is known to be a common complication resulting in poor quality of life. Aim of this randomized control trial(RCT) is to evaluate effectiveness of neuromonitoring during thyroid surgery for the preservation of these nerves.
Detailed description
The external branch of superior laryngeal nerves(EBSLNs) are important for voice quality. Injury to this nerve during thyroid surgery can manifest as ipsilateral paralysis of the cricothyroid muscle. Clinical symptoms may include: hoarseness, breathy voice, an increase in the rate of throat clearing, vocal fatigue, or diminished vocal frequency range, especially with regards to raising pitch. The amount of EBSLNs identified intraoperatively varies from 10% to 80%, while the rate of EBSLN injury reported in the literature is between 5% and 28%, depending on different evaluation methods. Advances in intraoperative neuromonitoring techniques would allow for EBSLN identification during thyroid surgery. However, there is controversy regarding usefulness in preserving EBSLN function using nerve monitoring system. The aim of the study is to evaluate effectiveness of neuromonitoring during thyroid surgery for the preservation of EBSLNs.
Interventions
intraoperative neuromonitoring to preserving external branch of superior laryngeal nerve during thyroid surgery
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* planned open thyroidectomy * acceptable clinical laboratory tests * understand clinical trials * no significant past medical history
Exclusion criteria
* planned radical neck dissection * hyperthyroidism history * history of laryngeal nerve palsy * laryngeal disease history * uncontrolled hypertension or diabetes mellitus or heart disease * anticoagulation or antiplatelet medication * stroke history * participated another clinical trials in 30days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of EBSLN during thyroid surgery | up to postoperative 12 months | Identification rate of EBSLN |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Location of EBSLN | up to postoperative 12 months | Classification of EBSLN according to Cernea classification |
| Vocal outcome | up to postoperative 12 months | Voice assessment using voice lab |
Countries
South Korea
Outcome results
None listed