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

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ClinicalTrials.gov Identifier: NCT03773120
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Su-jin Kim, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE April 12, 2018
First Posted Date  ICMJE December 12, 2018
Last Update Posted Date October 22, 2020
Actual Study Start Date  ICMJE April 6, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2018)
Identification of EBSLN during thyroid surgery [ Time Frame: up to postoperative 12 months ]
Identification rate of EBSLN
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2018)
  • Location of EBSLN [ Time Frame: up to postoperative 12 months ]
    Classification of EBSLN according to Cernea classification
  • Vocal outcome [ Time Frame: up to postoperative 12 months ]
    Voice assessment using voice lab
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Intraoperative Neuromonitoring of External Branch of Superior Laryngeal Nerve During Thyroid Surgery
Official Title  ICMJE Effectiveness of Intraoperative Neuromonitoring of the External Branch of the Superior Laryngeal Nerve During Thyroid Surgery
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Papillary, Follicular
Intervention  ICMJE Device: Using Neuromonitoring to find EBSLN
intraoperative neuromonitoring to preserving external branch of superior laryngeal nerve during thyroid surgery
Study Arms  ICMJE
  • Experimental: Using Neuromonitoring to find EBSLN
    With Neuromonitoring of the EBSLN using nerve monitoring system
    Intervention: Device: Using Neuromonitoring to find EBSLN
  • No Intervention: No Using Neuromonitoring to find EBSLN
    Without Neuromonitoring of the EBSLN using nerve monitoring system
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 9, 2018)
126
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sang Gab Yoon 82-10-4844-3654 sgyoon8282@gmail.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03773120
Other Study ID Numbers  ICMJE 1708-125-880
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Su-jin Kim, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seoul National University Hospital
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP