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

NCT06002984 | Recruiting DMC

• 1 other identifier: 2303-075-1411
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Laryngeal Nerve Injuries; Thyroidectomy; Voice Change

Keywords

External branch of the superior Laryngeal Nerve

Outcome Measures

Primary Outcomes (1)

• Identification rate of EBSLN

  Visual identification rate, Electrostimulatory identification rate

  during operation

Secondary Outcomes (7)

• Change of results about questionnaire for quality of voice

  up to postoperative 1 month, 3 months and 6 months

• Changes of Vocal outcome

  up to postoperative 1 month, 3 months and 6 months

• Measurements of Vocal function

  up to postoperative 1 month, 3 months and 6 months

• Vocal evaluation

  up to postoperative 1 month, 3 months and 6 months

• Changes of Vocal fold vibration patterns

  up to postoperative 1 month, 3 months and 6 months

Study Arms (2)

Using neuromonitoring to find EBSLN

EXPERIMENTAL

With neuromonitoring of the EBSLN using nerve monitoring system Intervention Device: Neuromonitoring to find EBSLN

Device: Using Neuromonitoring to find EBSLN

No using neuromonitoring to find EBSLN

NO INTERVENTION

Without neuromonitoring of the EBSLN using nerve monitoring system

Interventions

Using Neuromonitoring to find EBSLN DEVICE

intraoperative neuromonitoring to preserving external branch of superior laryngeal nerve during thyroid surgery

Using neuromonitoring to find EBSLN

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (9)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 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.

  PMID: 19958945 BACKGROUND

MeSH Terms

Conditions

Laryngeal Nerve Injuries; Dysphonia

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Injuries; Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Voice Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Su-Jin Kim, M.D, Ph.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hye Lim Bae, M.D

CONTACT

82-10-2664-6571; gpfla1206@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 21, 2023
• Study Start: November 24, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)