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

Recurrent Laryngeal Nerve Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02493881
• Other study ID #: SEEAH01
• Status: Completed
• Phase: N/A
• First received: June 26, 2015
• Last updated: July 9, 2015
• Start date: January 2012
• Est. completion date: March 2015

Study information

• Verified date: July 2015
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 337
• Est. completion date: March 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Recurrent Laryngeal Nerve Injuries

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

References & Publications (8)

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 — View Citation

Cernea CR, Hojaij FC, De Carlucci D Jr, Gotoda R, Plopper C, Vanderlei F, Brandão 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. — View 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;2 — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The diameters of the branches of the recurrent laryngeal nerves.	The branch diameters of the recurrent laryngeal nerves were compared between the two groups.	intraoperative
Secondary	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.	intraoperative