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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT03773120

Collaborator

(none)

Enrollment

Location

Arms

15.5

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Papillary, Follicular	Device: Using Neuromonitoring to find EBSLN	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 6, 2018

Actual Primary Completion Date :

Jul 23, 2019

Actual Study Completion Date :

Jul 23, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Identification of EBSLN during thyroid surgery [up to postoperative 12 months]
Identification rate of EBSLN

Secondary Outcome Measures

Location of EBSLN [up to postoperative 12 months]
Classification of EBSLN according to Cernea classification
Vocal outcome [up to postoperative 12 months]
Voice assessment using voice lab

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Su-jin Kim, Associate professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT03773120

Other Study ID Numbers:

1708-125-880

First Posted:

Dec 12, 2018

Last Update Posted:

Jan 28, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Su-jin Kim, Associate professor, Seoul National University Hospital

superior laryngeal nerve

Additional relevant MeSH terms:

Carcinoma, Papillary

Carcinoma, Papillary, Follicular

Study Results

No Results Posted as of Jan 28, 2022