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

NCT ID: NCT03773120

Last Updated: 2022-01-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-06
• Study Completion Date: 2019-07-23

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.

Conditions

Carcinoma, Papillary, Follicular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Using Neuromonitoring to find EBSLN

With Neuromonitoring of the EBSLN using nerve monitoring system

Group Type: EXPERIMENTAL

Using Neuromonitoring to find EBSLN

Intervention Type: DEVICE

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

No Using Neuromonitoring to find EBSLN

Without Neuromonitoring of the EBSLN using nerve monitoring system

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Using Neuromonitoring to find EBSLN

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Su-jin Kim

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

1708-125-880

Identifier Type: -

Identifier Source: org_study_id