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

Primary Purpose

Recurrent Laryngeal Nerve Injuries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intraoperative neuromonitoring
Sponsored by
Sisli Hamidiye Etfal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Recurrent Laryngeal Nerve Injuries focused on measuring Motor function of the extralaryngeal branches, intraoperative neuromonitoring, recurrent laryngeal nerve

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

    -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group 1

    Group 2

    Arm Description

    The RLNs having motor function on the anterior branch assessed by intraoperative neuromonitoring.

    RLNs having motor function on anterior and posterior branch assessed by intraoperative neuromonitoring.

    Outcomes

    Primary Outcome Measures

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

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

    Full Information

    First Posted
    June 26, 2015
    Last Updated
    July 9, 2015
    Sponsor
    Sisli Hamidiye Etfal Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02493881
    Brief Title
    Recurrent Laryngeal Nerve's Motor Function: Sometimes Motor Fibers May Also Be Located in The Posterior Branch
    Official Title
    Descriptive in Vivo Study of Evaluating the Motor Function of Recurrent Laryngeal Nerve's Extralaryngeal Branching Electromyographically.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sisli Hamidiye Etfal Training and Research Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Recurrent Laryngeal Nerve Injuries
    Keywords
    Motor function of the extralaryngeal branches, intraoperative neuromonitoring, recurrent laryngeal nerve

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    337 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Active Comparator
    Arm Description
    The RLNs having motor function on the anterior branch assessed by intraoperative neuromonitoring.
    Arm Title
    Group 2
    Arm Type
    Active Comparator
    Arm Description
    RLNs having motor function on anterior and posterior branch assessed by intraoperative neuromonitoring.
    Intervention Type
    Device
    Intervention Name(s)
    intraoperative neuromonitoring
    Intervention Description
    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 Outcome Measure Information:
    Title
    The evoked EMG potentials of the branches of the recurrent laryngeal nerves as microvolt, by intraoperative neuromonitoring.
    Description
    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.
    Time Frame
    intraoperative
    Secondary Outcome Measure Information:
    Title
    The diameters of the branches of the recurrent laryngeal nerves.
    Description
    The branch diameters of the recurrent laryngeal nerves were compared between the two groups.
    Time Frame
    intraoperative
    Title
    The branching distances of the recurrent laryngeal nerves.
    Description
    The branching distances of the recurrent laryngeal nerves till the entry point into the larynx, were compared between the two groups.
    Time Frame
    intraoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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. -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Adnan Isgor, Prof.
    Organizational Affiliation
    Bahcesehir University Medical Faculty, Department of General Surgery
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26054316
    Citation
    Gurleyik E. Location of motor fibers within branches of the recurrent laryngeal nerve with extralaryngeal terminal bifurcation; Functional identification by intraoperative neuromonitoring. Surgery. 2015 Nov;158(5):1339-44. doi: 10.1016/j.surg.2015.04.019. Epub 2015 Jun 6.
    Results Reference
    result
    PubMed Identifier
    24493270
    Citation
    Fontenot TE, Randolph GW, Friedlander PL, Masoodi H, Yola IM, Kandil E. Gender, race, and electrophysiologic characteristics of the branched recurrent laryngeal nerve. Laryngoscope. 2014 Oct;124(10):2433-7. doi: 10.1002/lary.24631. Epub 2014 Mar 25.
    Results Reference
    result
    PubMed Identifier
    19300223
    Citation
    Serpell JW, Yeung MJ, Grodski S. The motor fibers of the recurrent laryngeal nerve are located in the anterior extralaryngeal branch. Ann Surg. 2009 Apr;249(4):648-52. doi: 10.1097/SLA.0b013e31819ed9a4.
    Results Reference
    result
    PubMed Identifier
    21126710
    Citation
    Chiang FY, Lu IC, Chen HC, Chen HY, Tsai CJ, Hsiao PJ, Lee KW, Wu CW. Anatomical variations of recurrent laryngeal nerve during thyroid surgery: how to identify and handle the variations with intraoperative neuromonitoring. Kaohsiung J Med Sci. 2010 Nov;26(11):575-83. doi: 10.1016/S1607-551X(10)70089-9.
    Results Reference
    result
    PubMed Identifier
    19917921
    Citation
    Cernea CR, Hojaij FC, De Carlucci D Jr, Gotoda R, Plopper C, Vanderlei F, Brandao LG. Recurrent laryngeal nerve: a plexus rather than a nerve? Arch Otolaryngol Head Neck Surg. 2009 Nov;135(11):1098-102. doi: 10.1001/archoto.2009.151.
    Results Reference
    result
    PubMed Identifier
    19023612
    Citation
    Casella C, Pata G, Nascimbeni R, Mittempergher F, Salerni B. Does extralaryngeal branching have an impact on the rate of postoperative transient or permanent recurrent laryngeal nerve palsy? World J Surg. 2009 Feb;33(2):261-5. doi: 10.1007/s00268-008-9832-1.
    Results Reference
    result
    PubMed Identifier
    21497872
    Citation
    Kandil E, Abdel Khalek M, Aslam R, Friedlander P, Bellows CF, Slakey D. Recurrent laryngeal nerve: significance of the anterior extralaryngeal branch. Surgery. 2011 Jun;149(6):820-4. doi: 10.1016/j.surg.2011.02.012. Epub 2011 Apr 17.
    Results Reference
    result
    PubMed Identifier
    22136844
    Citation
    Kandil E, Abdelghani S, Friedlander P, Alrasheedi S, Tufano RP, Bellows CF, Slakey D. Motor and sensory branching of the recurrent laryngeal nerve in thyroid surgery. Surgery. 2011 Dec;150(6):1222-7. doi: 10.1016/j.surg.2011.09.002.
    Results Reference
    result

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

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