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Completed

NCT Number: NCT02493881

Recurrent Laryngeal Nerve's Motor Function: Sometimes Motor Fibers May Also Be Located in The Posterior Branch

The investigators hypothesized that, sometimes the posterior branch of the recurrent laryngeal nerve may also have motor function. The investigators aimed to evaluate motor function of the branches in the branching recurrent laryngeal nerves in this study.

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Key information

About this study

This study group consisted of consecutive patients, undergoing thyroid and parathyroid surgery with IONM. Both anterior and posterior branches of the recurrent laryngeal nerves were assessed separately by both electromyography endotracheal tube for adduction and finger palpation for detection of laryngeal twitch due to posterior cricoarytenoid abduction. The recurrent laryngeal nerves having motor function only in the anterior branches were defined as group 1, whereas the nerves having motor function both in the anterior and posterior branches were as group 2.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who underwent parathyroid/thyroid surgery with intraoperative neuromonitoring ,
  • Patients who had normal vocal cord functions preoperatively. -

Exclusion criteria

  • Preoperative recurrent laryngeal nerve palsy,
  • Intentional nerve transection because of cancer invasion,
  • Assessment failure of recurrent laryngeal nerve function due to the deficiency of the intraoperative neuromonitoring equipment,.
  • Parathyroidectomy operations that recurrent laryngeal nerves were not fully dissected.

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Treatment and study plan

intraoperative neuromonitoring

Device

NIM-Response 3.0 Intraoperative Neuromonitoring System (Medtronic Xomed, Jacksonville, FL, USA) was used to record the EMG amplitude signal for the anterior and/or posterior branches of recurrent laryngeal nerves (RLNs).

Primary outcomes

  1. The evoked EMG potentials of the branches of the recurrent laryngeal nerves as microvolt, by intraoperative neuromonitoring.

    Time frame: intraoperative

    The nerves , due to having motor functions whether on their anterior or posterior branches, were divided into two groups. The amplitudes of the anterior and posterior branches within the group 2 were compared.

Secondary outcomes

  1. The diameters of the branches of the recurrent laryngeal nerves.

    Time frame: intraoperative

    The branch diameters of the recurrent laryngeal nerves were compared between the two groups.

  2. The branching distances of the recurrent laryngeal nerves.

    Time frame: intraoperative

    The branching distances of the recurrent laryngeal nerves till the entry point into the larynx, were compared between the two groups.

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Official study title

Descriptive in Vivo Study of Evaluating the Motor Function of Recurrent Laryngeal Nerve's Extralaryngeal Branching Electromyographically.

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jul 10, 2015
Registry last updated
Jul 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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