Clinical trial NCT01395134: Visualization Versus Neuromonitoring of the External Branch of the Superior Laryngeal Nerve During Thyroidectomy.
Official title: Randomized Controlled Trial of Visualization Versus Neuromonitoring of the External Branch of the Superior Laryngeal Nerve During Thyroidectomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid,
Goiter,
Keywords: External branch of the superior laryngeal nerve,
Recurrent laryngeal nerve,
Intraoperative neuromonitoring,
Thyroid surgery
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2011-07-15
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Injury to the external branch of the superior laryngeal nerve (EBSLN) during thyroidectomy results in lowered fundamental frequency of the voice and worsened voice performance in producing high-frequency sounds. It remains unclear if use of intraoperative nerve monitoring (IONM) can improve clinical outcome of thyroidectomy in terms of preserved individual voice performance. This study was designed to test that hypothesis.

Detailed description: Phonation changes following thyroidectomy have been reported in many investigations. They are considered to be multifactorial in origin and can be a consequence of laryngeal nerve injury or other events during thyroidectomy including arytenoids trauma after endotracheal intubation, cricothyroid dysfunction, strap muscle malfunction or lesion of the perithyroidal neural plexus, laryngotracheal fixation with impairment of vertical movement and psychological reaction to the operation. Injury to the external branch of the superior laryngeal nerve (EBSLN) can occur during the dissection and clamping of the superior thyroid vessels and the prevalence of this complication has been reported from 0.5% to 58%. This injury causes a complete paralysis of the cricothyroid muscle which results in lowered fundamental frequency of the voice and worsened voice performance in producing high-frequency sounds. Intraoperative nerve monitoring (IONM) has gained widespread acceptance as an adjunct to the gold standard of visual nerve identification and this technique can be used to identify both the recurrent laryngeal nerve (RLN) and the EBSLN. However, it remains unclear if there is any IONM added-value to the clinical outcome of thyroidectomy in terms of preserved individual voice performance. This study was designed to test that hypothesis.

Eligibility criteria: Inclusion Criteria:

* thyroid pathology qualified for first-time bilateral neck surgery in a female patient with small to moderate sized goiter (below 100 ml in volume).

Exclusion Criteria:

* male gender,
* previous neck surgery,
* unilateral thyroid pathology eligible for unilateral lobectomy,
* goiter volume above 100 ml,
* preoperatively diagnosed RLN palsy,
* abnormal preoperative voice assessment on GRBAS scale,
* pregnancy or lactation,
* age below 18 years,
* high-risk patients ASA 4 grade (American Society of Anesthesiology),
* inability to comply with the scheduled follow-up protocol.

Primary outcomes:
measure: The identification rate of the external branch of the superior laryngeal nerve.
timeFrame: up to 6 months postoperatively
Secondary outcomes:
measure: Anatomical variability of the external branch of the superior laryngeal nerve according to Cernea classification.
timeFrame: up to 6 months postoperatively
measure: The changes in postoperative voice performance.
timeFrame: up to 6 months postoperatively
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Jagiellonian University, College of Medicine, Department of Endocrine Surgery, 3rd Chair of General Surgery
Study officials:
affiliation: Jagiellonian University, College of Medicine
name: Marcin Barczynski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cernea CR, Ferraz AR, Furlani J, Monteiro S, Nishio S, Hojaij FC, Dutra Junior A, Marques LA, Pontes PA, Bevilacqua RG. Identification of the external branch of the superior laryngeal nerve during thyroidectomy. Am J Surg. 1992 Dec;164(6):634-9. doi: 10.1016/s0002-9610(05)80723-8.
citation: Cernea CR, Ferraz AR, Nishio S, Dutra A Jr, Hojaij FC, dos Santos LR. Surgical anatomy of the external branch of the superior laryngeal nerve. Head Neck. 1992 Sep-Oct;14(5):380-3. doi: 10.1002/hed.2880140507.
citation: Randolph GW, Dralle H; International Intraoperative Monitoring Study Group; Abdullah H, Barczynski M, Bellantone R, Brauckhoff M, Carnaille B, Cherenko S, Chiang FY, Dionigi G, Finck C, Hartl D, Kamani D, Lorenz K, Miccolli P, Mihai R, Miyauchi A, Orloff L, Perrier N, Poveda MD, Romanchishen A, Serpell J, Sitges-Serra A, Sloan T, Van Slycke S, Snyder S, Takami H, Volpi E, Woodson G. Electrophysiologic recurrent laryngeal nerve monitoring during thyroid and parathyroid surgery: international standards guideline statement. Laryngoscope. 2011 Jan;121 Suppl 1:S1-16. doi: 10.1002/lary.21119.
citation: Lifante JC, McGill J, Murry T, Aviv JE, Inabnet WB 3rd. A prospective, randomized trial of nerve monitoring of the external branch of the superior laryngeal nerve during thyroidectomy under local/regional anesthesia and IV sedation. Surgery. 2009 Dec;146(6):1167-73. doi: 10.1016/j.surg.2009.09.023.
citation: Bellantone R, Boscherini M, Lombardi CP, Bossola M, Rubino F, De Crea C, Alesina P, Traini E, Cozza T, D'alatri L. Is the identification of the external branch of the superior laryngeal nerve mandatory in thyroid operation? Results of a prospective randomized study. Surgery. 2001 Dec;130(6):1055-9. doi: 10.1067/msy.2001.118375.
citation: Barczynski M, Konturek A, Stopa M, Honowska A, Nowak W. Randomized controlled trial of visualization versus neuromonitoring of the external branch of the superior laryngeal nerve during thyroidectomy. World J Surg. 2012 Jun;36(6):1340-7. doi: 10.1007/s00268-012-1547-7.