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Clinical Trials/NCT02761239
NCT02761239
Completed
N/A

Descriptive In Vivo Study of Evaluating the Innervation of The Human Cricopharyngeal Muscle By The Recurrent Laryngeal Nerve and External Branch of The Superior Laryngeal Nerve

Sisli Hamidiye Etfal Training and Research Hospital0 sites100 target enrollmentFebruary 2015
ConditionsLarynx

Overview

Phase
N/A
Intervention
Not specified
Conditions
Larynx
Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
Enrollment
100
Primary Endpoint
The cricopharyngeal muscle innervation pattern that is evaluated by visual contractions and EMG evoked potentials, with stimulation of the nerves
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The investigators hypothesized that, external branch of the superior laryngeal nerve (EBSLN) and/or recurrent laryngeal nerve (RLN) contribute to the motor function of the human cricopharyngeal muscle (CP). The investigators aimed to assess the contribution of the laryngeal nerves (EBSLN and RLN) to the motor activity of the cricopharyngeal muscle, during thyroidectomy with intraoperative neuromonitoring (IONM).

Detailed Description

This study group consisted of a consecutive patients undergoing thyroid surgery with intraoperative neuromonitoring (NIM 3.0 Nerve Monitoring Systeme (Medtronic Xomed, Jacksonville, FL, USA) ) for various diseases. In all patients, each side of the neck operated was considered as a separate entity in our study. EMG recordings were accomplished with a pair of needle electrodes inserted into the CP and mid-portion of the CT muscle that is located on the superior side of the RLN, which were plugged into the third and fourth channels of interface-connector box, respectively, at the end of the thyroidectomy or lobectomy. The investigators evaluated the innervation pattern of the CT muscle in an other study. Therefore the EBSLN is the main supplier of the CT muscle, the EMG findings of the CT muscle were used to confirm it, in this study. EBSLN, pharyngeal plexus (PP), RLN and vagus nerve were stimulated with a monopolar stimulator probe at 1 mA. While stimulating these nerves, the ipsilateral CP muscle was visually observed for possible contractions and electromyographic recordings were obtained with the 4-channel NIM 3.0 Nerve Monitoring System.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
November 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Mehmet Uludag

Associated Professor

Sisli Hamidiye Etfal Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • The patients who underwent thyroidectomy.

Exclusion Criteria

  • Preoperative RLN palsy
  • Thyroid cancer with massive extrathyroidal extension
  • Intentional nerve transection because of cancer invasion
  • The assessment failure of nerve function due to the technical deficiency of the IONM equipment

Outcomes

Primary Outcomes

The cricopharyngeal muscle innervation pattern that is evaluated by visual contractions and EMG evoked potentials, with stimulation of the nerves

Time Frame: up to 9 months

Secondary Outcomes

  • The comparison of the EMG amplitudes obtained with the stimulation of the recurrent laryngeal nerve (RLN), vagus nerve, external branch of the superior laryngeal nerve (EBSLN) and pharyngeal plexus.(up to 9 months)

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