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

NCT ID: NCT06002984

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-24
• Study Completion Date: 2026-12-31

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.

Detailed Description

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.

Conditions

Laryngeal Nerve Injuries; Thyroidectomy; Voice Change

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Using neuromonitoring to find EBSLN

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

Group Type: EXPERIMENTAL

Using Neuromonitoring to find EBSLN

Intervention Type: DEVICE

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

No using neuromonitoring to find EBSLN

Without neuromonitoring of the EBSLN using nerve monitoring system

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Using Neuromonitoring to find EBSLN

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Su-jin Kim

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Su-Jin Kim, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Hye Lim Bae, M.D

Role: CONTACT

gpfla1206@gmail.com

82-10-2664-6571

Facility Contacts

Su-jin Kim

Role: primary

su.jin.kim.md@gmail.com

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

2303-075-1411

Identifier Type: -

Identifier Source: org_study_id