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Injury to the external branch of the superior laryngeal nerve (EBSLN) during thyroidectomy results in lowered fundamental frequency of the voice and worsened voice performance in producing high-frequency sounds. It remains unclear if use of intraoperative nerve monitoring (IONM) can improve clinical outcome of thyroidectomy in terms of preserved individual voice performance. This study was designed to test that hypothesis.
Phonation changes following thyroidectomy have been reported in many investigations. They are considered to be multifactorial in origin and can be a consequence of laryngeal nerve injury or other events during thyroidectomy including arytenoids trauma after endotracheal intubation, cricothyroid dysfunction, strap muscle malfunction or lesion of the perithyroidal neural plexus, laryngotracheal fixation with impairment of vertical movement and psychological reaction to the operation. Injury to the external branch of the superior laryngeal nerve (EBSLN) can occur during the dissection and clamping of the superior thyroid vessels and the prevalence of this complication has been reported from 0.5% to 58%. This injury causes a complete paralysis of the cricothyroid muscle which results in lowered fundamental frequency of the voice and worsened voice performance in producing high-frequency sounds. Intraoperative nerve monitoring (IONM) has gained widespread acceptance as an adjunct to the gold standard of visual nerve identification and this technique can be used to identify both the recurrent laryngeal nerve (RLN) and the EBSLN. However, it remains unclear if there is any IONM added-value to the clinical outcome of thyroidectomy in terms of preserved individual voice performance. This study was designed to test that hypothesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visualization of the EBSLN and RLN | No Intervention | Visual inspection of the nerves. | |
| Neuromonitoring of the EBSLN and RLN | Experimental | Electrical stimulation and monitoring of the nerves' function. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromonitoring | Device | Electrical stimulation of the nerve: 1 mA, 4 Hz with surface electromyography of the vocalis muscles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The identification rate of the external branch of the superior laryngeal nerve. | up to 6 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Anatomical variability of the external branch of the superior laryngeal nerve according to Cernea classification. | up to 6 months postoperatively | |
| The changes in postoperative voice performance. | The voice assessment included pre- and postoperative videostrobolaryngoscopy and analysis of maximum phonation time (MPT), voice level (VL), fundamental frequency (Fo), and voice quality rating on GRBAS scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcin Barczynski, MD, PhD | Jagiellonian University, College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jagiellonian University, College of Medicine, Department of Endocrine Surgery, 3rd Chair of General Surgery | Krakow | 31-202 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1463114 | Background | Cernea CR, Ferraz AR, Furlani J, Monteiro S, Nishio S, Hojaij FC, Dutra Junior A, Marques LA, Pontes PA, Bevilacqua RG. Identification of the external branch of the superior laryngeal nerve during thyroidectomy. Am J Surg. 1992 Dec;164(6):634-9. doi: 10.1016/s0002-9610(05)80723-8. | |
| 1399571 | Background | Cernea CR, Ferraz AR, Nishio S, Dutra A Jr, Hojaij FC, dos Santos LR. Surgical anatomy of the external branch of the superior laryngeal nerve. Head Neck. 1992 Sep-Oct;14(5):380-3. doi: 10.1002/hed.2880140507. |
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| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D006042 | Goiter |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
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|
| up to 6 months postoperatively |
| 21181860 | Background | Randolph GW, Dralle H; International Intraoperative Monitoring Study Group; Abdullah H, Barczynski M, Bellantone R, Brauckhoff M, Carnaille B, Cherenko S, Chiang FY, Dionigi G, Finck C, Hartl D, Kamani D, Lorenz K, Miccolli P, Mihai R, Miyauchi A, Orloff L, Perrier N, Poveda MD, Romanchishen A, Serpell J, Sitges-Serra A, Sloan T, Van Slycke S, Snyder S, Takami H, Volpi E, Woodson G. Electrophysiologic recurrent laryngeal nerve monitoring during thyroid and parathyroid surgery: international standards guideline statement. Laryngoscope. 2011 Jan;121 Suppl 1:S1-16. doi: 10.1002/lary.21119. |
| 19958945 | Background | Lifante JC, McGill J, Murry T, Aviv JE, Inabnet WB 3rd. A prospective, randomized trial of nerve monitoring of the external branch of the superior laryngeal nerve during thyroidectomy under local/regional anesthesia and IV sedation. Surgery. 2009 Dec;146(6):1167-73. doi: 10.1016/j.surg.2009.09.023. |
| 11742338 | Background | Bellantone R, Boscherini M, Lombardi CP, Bossola M, Rubino F, De Crea C, Alesina P, Traini E, Cozza T, D'alatri L. Is the identification of the external branch of the superior laryngeal nerve mandatory in thyroid operation? Results of a prospective randomized study. Surgery. 2001 Dec;130(6):1055-9. doi: 10.1067/msy.2001.118375. |
| 22402975 | Derived | Barczynski M, Konturek A, Stopa M, Honowska A, Nowak W. Randomized controlled trial of visualization versus neuromonitoring of the external branch of the superior laryngeal nerve during thyroidectomy. World J Surg. 2012 Jun;36(6):1340-7. doi: 10.1007/s00268-012-1547-7. |