Effectiveness of Intraoperative Neuromonitoring of External Branch of Superior Laryngeal Nerve in Thyroid Surgery

Официальное название

Effectiveness of Intraoperative Neuromonitoring to Identify and Preserve External Branch of Superior Laryngeal Nerve During Thyroid Surgery

Обзор

The frequent occurrence of impaired function in the external branch of the superior laryngeal nerves following thyroid surgery is recognized as a prevalent complication leading to a diminished quality of life. The objective of this randomized controlled trial (RCT) is to assess the efficacy of neuromonitoring during thyroid surgery in order to safeguard the integrity of these nerves.

Подробное описание

With increased interest in quality of life after thyroidectomy, preservation of proper vocal cord function and voice quality is an important issue in thyroid surgery. External branch of the superior laryngeal nerve (EBSLN) and recurrent laryngeal nerve (RLN) are crucial organs for innervation and integration of laryngeal muscular system. The EBSLN innervates the cricothyroid muscle (CTM), which is important in adjusting the tension and length of the vocal cords. Damage of the EBSLN leads to CTM dysfunction, resulting in difficulty with high pitch phonation and decreased pitch range and reduced voice projection, which are important for voice professionals. As the intraoperative neuromonitoring was utilized as an adjunctive and objective tool to confirm the nerve presence and integrity, application of the intraoperative neuromonitoring system to confirm EBSLN function pre- and post-dissection of the upper thyroid pole can be regarded as an effective method to preserve cricothyroid muscle function. However, it remains unclear whether there is any intraoperative neuromonitoring techniques-added value to the clinical outcome of thyroidectomy in terms of identification of EBSLN and preserved voice performance. Therefore, this study could provide strong evidence of the application of the intraoperative neuromonitoring during thyroid surgery to identify and preserve EBSLN function.

Вмешательства

• Устройство Using Neuromonitoring to find EBSLN
  intraoperative neuromonitoring to preserving external branch of superior laryngeal nerve during thyroid surgery

Первичные конечные точки

• Identification rate of EBSLN [Срок оценки: during operation]

Вторичные конечные точки (7)

• Change of results about questionnaire for quality of voice [Срок оценки: up to postoperative 1 month, 3 months and 6 months]
• Changes of Vocal outcome [Срок оценки: up to postoperative 1 month, 3 months and 6 months]
• Measurements of Vocal function [Срок оценки: up to postoperative 1 month, 3 months and 6 months]
• Vocal evaluation [Срок оценки: up to postoperative 1 month, 3 months and 6 months]
• Changes of Vocal fold vibration patterns [Срок оценки: up to postoperative 1 month, 3 months and 6 months]
• Changes of Vocal outcome by Computerized Acoustic Analysis [Срок оценки: up to postoperative 1 month, 3 months and 6 months]
• Changes of Voice Pitch [Срок оценки: up to postoperative 1 month, 3 months and 6 months]

Критерии участия

Критерии включения

• Patients who are scheduled to undergo thyroid surgery
• Patients who understand and agree to take part in this study

Критерии исключения

• If the thyroid tumor is suspected to invade adjacent organs (esophagus, trachea, carotid artery, jugular vein etc.)
• Patients who are required with lateral compartment neck dissection
• Patients with recurrent thyroid cancer
• Patients with palsy of recurrent laryngeal nerve or superior laryngeal nerve external branch in the past or present
• Patients with a history of vocal cord and larynx disease
• History of hyperthyroidism (e.g., Graves' disease)
• Taking anticoagulants (aspirin, warfarin, etc.) before surgery
• Disorders of coagulation
• In the case of women, pregnant women and breastfeeding patients
• Patients judged inappropriate by clinical trial researcher

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

South Korea · 1 центр

• Seoul National University Hospital — Seoul

Публикации

• Kim SJ, Lee KE, Oh BM, Oh EM, Bae DS, Choi JY, Myong JP, Youn YK. Intraoperative neuromonitoring of the external branch of the superior laryngeal nerve during robotic thyroid surgery: a preliminary prospective study. Ann Surg Treat Res. 2015 Nov;89(5):233-9. doi: 10.4174/astr.2015.89.5.233. Epub 2015 Oct 28. PMID 26576402
• Kim JI, Kim SJ, Xu Z, Kwak J, Ahn JH, Yu HW, Chai YJ, Choi JY, Lee KE. Efficacy of Intraoperative Neuromonitoring in Reoperation for Recurrent Thyroid Cancer Patients. Endocrinol Metab (Seoul). 2020 Dec;35(4):918-924. doi: 10.3803/EnM.2020.778. Epub 2020 Dec 23. PMID 33397044
• Potenza AS, Phelan EA, Cernea CR, Slough CM, Kamani DV, Darr A, Zurakowski D, Randolph GW. Normative intra-operative electrophysiologic waveform analysis of superior laryngeal nerve external branch and recurrent laryngeal nerve in patients undergoing thyroid surgery. World J Surg. 2013 Oct;37(10):2336-42. doi: 10.1007/s00268-013-2148-9. PMID 23838931
• 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. PMID 22402975
• Jonas J, Bahr R. Neuromonitoring of the external branch of the superior laryngeal nerve during thyroid surgery. Am J Surg. 2000 Mar;179(3):234-6. doi: 10.1016/s0002-9610(00)00308-1. PMID 10827327
• Babinska D, Barczynski M, Oseka T, Sledzinski M, Lachinski AJ. Comparison of perioperative stress in patients undergoing thyroid surgery with and without neuromonitoring-a pilot study. Langenbecks Arch Surg. 2017 Jun;402(4):719-725. doi: 10.1007/s00423-016-1457-5. Epub 2016 Jun 14. PMID 27299585
• Cirocchi R, Arezzo A, D'Andrea V, Abraha I, Popivanov GI, Avenia N, Gerardi C, Henry BM, Randolph J, Barczynski M. Intraoperative neuromonitoring versus visual nerve identification for prevention of recurrent laryngeal nerve injury in adults undergoing thyroid surgery. Cochrane Database Syst Rev. 2019 Jan 19;1(1):CD012483. doi: 10.1002/14651858.CD012483.pub2. PMID 30659577
• Dionigi G, Boni L, Rovera F, Bacuzzi A, Dionigi R. Neuromonitoring and video-assisted thyroidectomy: a prospective, randomized case-control evaluation. Surg Endosc. 2009 May;23(5):996-1003. doi: 10.1007/s00464-008-0098-3. Epub 2008 Sep 21. PMID 18806939

Идентификаторы

NCT: NCT06002984 · 2303-075-1411

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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