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

NCT02493881 | Completed

• 1 other identifier: SEEAH01
• Study Type: interventional
• Target: 337
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Recurrent Laryngeal Nerve Injuries

Keywords

Motor function of the extralaryngeal branches; intraoperative neuromonitoring; recurrent laryngeal nerve

Outcome Measures

Primary Outcomes (1)

• 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.

  intraoperative

Secondary Outcomes (2)

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

  intraoperative

• The branching distances of the recurrent laryngeal nerves.

  intraoperative

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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

Device: intraoperative neuromonitoring

Group 2

ACTIVE COMPARATOR

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

Device: intraoperative neuromonitoring

Interventions

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).

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Related Publications (8)

• 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.

  PMID: 26054316 RESULT

• 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.

  PMID: 24493270 RESULT

• 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.

  PMID: 19300223 RESULT

• 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.

  PMID: 21126710 RESULT

• 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.

  PMID: 19917921 RESULT

• 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.

  PMID: 19023612 RESULT

• 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.

  PMID: 21497872 RESULT

• 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.

  PMID: 22136844 RESULT

MeSH Terms

Conditions

Recurrent Laryngeal Nerve Injuries

Interventions

Intraoperative Neurophysiological Monitoring

Condition Hierarchy (Ancestors)

Laryngeal Nerve Injuries; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Injuries; Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Monitoring, Intraoperative; Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Neurophysiological Monitoring; Surgical Procedures, Operative

Study Officials

• Adnan Isgor, Prof.

  Bahcesehir University Medical Faculty, Department of General Surgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: July 10, 2015
• Study Start: January 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: March 1, 2015
• Last Updated: July 10, 2015

Record last verified: 2015-07