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

July 9, 2015 updated by: Mehmet Uludag, Sisli Hamidiye Etfal Training and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

337

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Preoperative recurrent laryngeal nerve palsy,
  2. Intentional nerve transection because of cancer invasion,
  3. Assessment failure of recurrent laryngeal nerve function due to the deficiency of the intraoperative neuromonitoring equipment,.

  4. Parathyroidectomy operations that recurrent laryngeal nerves were not fully dissected.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
The RLNs having motor function on the anterior branch assessed by intraoperative neuromonitoring.
Device: intraoperative neuromonitoring
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).
Active Comparator: Group 2
RLNs having motor function on anterior and posterior branch assessed by intraoperative neuromonitoring.
Device: intraoperative neuromonitoring
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
intraoperative
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.
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Investigators

  • Study Director: Adnan Isgor, Prof., Bahcesehir University Medical Faculty, Department of General Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

June 26, 2015

First Submitted That Met QC Criteria

July 9, 2015

First Posted (Estimate)

July 10, 2015

Study Record Updates

Last Update Posted (Estimate)

July 10, 2015

Last Update Submitted That Met QC Criteria

July 9, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEEAH01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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