Neural Monitoring of the Superior Laryngeal Nerve in Thyroid Surgery

NCT02395146 | Completed

• 1 other identifier: 14-04-06-SUR
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Thyroid surgeons place an enormous amount of importance and rightly so to the preservation of the recurrent laryngeal nerve (RLN) during thyroidectomies. A good knowledge of the anatomy of the nerve and meticulous dissection technique and intraoperative identification of the nerve are crucial to the anatomic and functional integrity of the nerve. The use of intraoperative neural monitoring to aid the surgeon in the identification of the RLN has gained acceptance and is considered standard practice in several units. However, lesser emphasis has been placed historically on the identification and preservation of the external branch of the superior laryngeal nerve (EBSLN) during thyroid surgery. The EBSLN supplies the cricothyroid muscle that controls pitch variation during phonation. Unlike damage to the recurrent laryngeal nerve which manifests readily as vocal cord paralysis, intraoperative damage to EBSLN is difficult to assess postoperatively as visual assessment of the larynx is not indicative of the integrity of the nerve. Injury of the EBSLN can cause weakness or complete paralysis of the ipsilateral cricothyroid muscle. Patients may report a deeper voice or an inability to produce high pitched sounds. Patients may also complain of weakness, tightness of the voice, and require extra effort to speak. Of note, voice changes with EBSLN injury are subtle in the general population but can be devastating in patients who depend on their voice for a living. Importantly, EBSLN injury is reported in upto 50% of thyroid surgery in contrast to 12% of recurrent laryngeal nerve injury during thyroid surgery. The new guidelines published in the Laryngoscope recommend routine intraoperative neural monitoring of EBSLN. The Investigators have a functional system in use currently for monitoring recurrent laryngeal nerve intraoperatively and propose to study the impact of monitoring the EBSLN using the same neural monitoring device to improve voice results following thyroid surgery.

Conditions

Laryngeal Nerve; Thyroid Surgery

Outcome Measures

Primary Outcomes (1)

• Intact external branch of the superior laryngeal nerve

  Review and feedback via questionnaire of superior laryngeal nerve

  6 months

Study Arms (2)

Monitoring

EXPERIMENTAL

intraoperative EBSLN monitoring will take place

Procedure: Monitoring

Non-Monitoring

NO INTERVENTION

No intraoperative EBSLN monitoring will take place (standard practice)

Interventions

Monitoring PROCEDURE

intraoperative EBSLN monitoring

Monitoring

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing diagnostic hemithyroidectomies (thyroid nodules 5 cm or less).
• age 18 and over
• able to provide informed consent

You may not qualify if:

• Patients who develop a recurrent laryngeal nerve palsy following surgery will be excluded from the study.
• Patients who withdraw consent during or after study
• Patients with pre-existing laryngeal pathology like reinkes edema, vocal cord nodules, laryngeal inflammation, previous laryngeal surgery etc
• Pregnant women (confirmed by history and routine pregnancy test)
• Those unable to give informed consent
• Previous major neck surgery such as neck dissections, laryngeal surgery, carotid endarterectomies, parathyroid and thyroid surgery.

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead

Study Sites (1)

The Royal Wolverhampton NHS Trust

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: March 20, 2015
• Study Start: September 9, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: June 19, 2019

Record last verified: 2019-06

Locations

GB (1)