Clinical trial NCT02493881: 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
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Laryngeal Nerve Injuries
Keywords: Motor function of the extralaryngeal branches
intraoperative neuromonitoring
recurrent laryngeal nerve
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2015-07-10
Enrollment: 337
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

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Primary outcomes:
measure: The evoked EMG potentials of the branches of the recurrent laryngeal nerves as microvolt, by intraoperative neuromonitoring.
timeFrame: intraoperative
Secondary outcomes:
measure: The diameters of the branches of the recurrent laryngeal nerves.
timeFrame: intraoperative
measure: The branching distances of the recurrent laryngeal nerves.
timeFrame: intraoperative
Other outcomes:
Locations:
Study officials:
affiliation: Bahcesehir University Medical Faculty, Department of General Surgery
name: Adnan Isgor, Prof.
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.
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.