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Major study protocol changes
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Using Neuromonitoring to find EBSLN | Experimental | With Neuromonitoring of the EBSLN using nerve monitoring system |
|
| No Using Neuromonitoring to find EBSLN | No Intervention | Without Neuromonitoring of the EBSLN using nerve monitoring system |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Using Neuromonitoring to find EBSLN | Device | intraoperative neuromonitoring to preserving external branch of superior laryngeal nerve during thyroid surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identification of EBSLN during thyroid surgery | Identification rate of EBSLN | up to postoperative 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Location of EBSLN | Classification of EBSLN according to Cernea classification | up to postoperative 12 months |
| Vocal outcome | Voice assessment using voice lab |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
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| ID | Term |
|---|---|
| D018265 | Carcinoma, Papillary, Follicular |
| ID | Term |
|---|---|
| D018263 | Adenocarcinoma, Follicular |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| up to postoperative 12 months |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000231 | Adenocarcinoma, Papillary |