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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-79
SponsorSeoul National University Hospital

About this trial

The frequent occurrence of impaired function in the external branch of the superior laryngeal nerves following thyroid surgery is recognized as a prevalent complication leading to a diminished quality of life. The objective of this randomized controlled trial (RCT) is to assess the efficacy of neuromonitoring during thyroid surgery in order to safeguard the integrity of these nerves.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who are scheduled to undergo thyroid surgery

Patients who understand and agree to take part in this study

Disqualifiers

If the thyroid tumor is suspected to invade adjacent organs (esophagus, trachea, carotid artery, jugular vein etc.)

Patients who are required with lateral compartment neck dissection

Patients with recurrent thyroid cancer

Patients with palsy of recurrent laryngeal nerve or superior laryngeal nerve external branch in the past or present

Trial design

Design model

Parallel

Treatments tested in this trial

  • Using Neuromonitoring to find EBSLN

    Device

    intraoperative neuromonitoring to preserving external branch of superior laryngeal nerve during thyroid surgery

Treatment groups

94 Participants
are divided into 2 treatment groups
Group A: Using neuromonitoring to find EBSLNExperimental treatment 1 intervention
Group B: No using neuromonitoring to find EBSLNNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Identification rate of EBSLN

Visual identification rate, Electrostimulatory identification rate

Time frame
during operation

Secondary outcomes

1

Change of results about questionnaire for quality of voice

Voice Handicap Index-10 \[0\~40\], higher scores mean worse voice disorder

Time frame
up to postoperative 1 month, 3 months and 6 months
2

Changes of Vocal outcome

Visual Analogue Scales (VAS) \[0\~100%\], 0% = no voice, full disability ; 100% = normal voice

Time frame
up to postoperative 1 month, 3 months and 6 months
3

Measurements of Vocal function

Maximum Phonation Time (MPT)

Time frame
up to postoperative 1 month, 3 months and 6 months
4

Vocal evaluation

GRBAS (Grade, Rough, Breathy, Asthenia, and Strain)

Time frame
up to postoperative 1 month, 3 months and 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.