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

January 13, 2022 updated by: Su-jin Kim, Seoul National University Hospital

Effectiveness of Intraoperative Neuromonitoring of the External Branch of the Superior Laryngeal Nerve During Thyroid Surgery

The paralysis of the external branch of superior laryngeal nerves after thyroid surgery is known to be a common complication resulting in poor quality of life. Aim of this randomized control trial(RCT) is to evaluate effectiveness of neuromonitoring during thyroid surgery for the preservation of these nerves.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The external branch of superior laryngeal nerves(EBSLNs) are important for voice quality. Injury to this nerve during thyroid surgery can manifest as ipsilateral paralysis of the cricothyroid muscle. Clinical symptoms may include: hoarseness, breathy voice, an increase in the rate of throat clearing, vocal fatigue, or diminished vocal frequency range, especially with regards to raising pitch. The amount of EBSLNs identified intraoperatively varies from 10% to 80%, while the rate of EBSLN injury reported in the literature is between 5% and 28%, depending on different evaluation methods. Advances in intraoperative neuromonitoring techniques would allow for EBSLN identification during thyroid surgery. However, there is controversy regarding usefulness in preserving EBSLN function using nerve monitoring system. The aim of the study is to evaluate effectiveness of neuromonitoring during thyroid surgery for the preservation of EBSLNs.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • planned open thyroidectomy
  • acceptable clinical laboratory tests
  • understand clinical trials
  • no significant past medical history

Exclusion Criteria:

  • planned radical neck dissection
  • hyperthyroidism history
  • history of laryngeal nerve palsy
  • laryngeal disease history
  • uncontrolled hypertension or diabetes mellitus or heart disease
  • anticoagulation or antiplatelet medication
  • stroke history
  • participated another clinical trials in 30days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Using Neuromonitoring to find EBSLN
With Neuromonitoring of the EBSLN using nerve monitoring system
Device: Using Neuromonitoring to find EBSLN
intraoperative neuromonitoring to preserving external branch of superior laryngeal nerve during thyroid surgery
No Intervention: No Using Neuromonitoring to find EBSLN
Without Neuromonitoring of the EBSLN using nerve monitoring system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of EBSLN during thyroid surgery
Time Frame: up to postoperative 12 months
Identification rate of EBSLN
up to postoperative 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Location of EBSLN
Time Frame: up to postoperative 12 months
Classification of EBSLN according to Cernea classification
up to postoperative 12 months
Vocal outcome
Time Frame: up to postoperative 12 months
Voice assessment using voice lab
up to postoperative 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2018

Primary Completion (Actual)

July 23, 2019

Study Completion (Actual)

July 23, 2019

Study Registration Dates

First Submitted

April 12, 2018

First Submitted That Met QC Criteria

December 9, 2018

First Posted (Actual)

December 12, 2018

Study Record Updates

Last Update Posted (Actual)

January 28, 2022

Last Update Submitted That Met QC Criteria

January 13, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1708-125-880

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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