Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773120
Recruitment Status : Terminated (Major study protocol changes)
First Posted : December 12, 2018
Last Update Posted : January 28, 2022
Sponsor:
Information provided by (Responsible Party):
Su-jin Kim, Seoul National University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : April 6, 2018
Actual Primary Completion Date : July 23, 2019
Actual Study Completion Date : July 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Identification of EBSLN during thyroid surgery [ Time Frame: up to postoperative 12 months ]
    Identification rate of EBSLN


Secondary Outcome Measures :
  1. Location of EBSLN [ Time Frame: up to postoperative 12 months ]
    Classification of EBSLN according to Cernea classification

  2. Vocal outcome [ Time Frame: up to postoperative 12 months ]
    Voice assessment using voice lab


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773120


Locations
Layout table for location information
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Su-jin Kim, Associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03773120    
Other Study ID Numbers: 1708-125-880
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: January 28, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Su-jin Kim, Seoul National University Hospital:
superior laryngeal nerve
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Papillary
Carcinoma, Papillary, Follicular
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Squamous Cell
Adenocarcinoma, Follicular
Adenocarcinoma
Adenocarcinoma, Papillary