Visualization Versus Neuromonitoring of the External Branch of the Superior Laryngeal Nerve During Thyroidectomy.

NCT01395134 | Completed DMC

• 1 other identifier: BBN/501/ZKL/1446
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid,; Goiter,

Keywords

External branch of the superior laryngeal nerve,; Recurrent laryngeal nerve,; Intraoperative neuromonitoring,; Thyroid surgery

Outcome Measures

Primary Outcomes (1)

• The identification rate of the external branch of the superior laryngeal nerve.

  up to 6 months postoperatively

Secondary Outcomes (2)

• Anatomical variability of the external branch of the superior laryngeal nerve according to Cernea classification.

  up to 6 months postoperatively

• The changes in postoperative voice performance.

  up to 6 months postoperatively

Study Arms (2)

Visualization of the EBSLN and RLN

NO INTERVENTION

Visual inspection of the nerves.

Neuromonitoring of the EBSLN and RLN

EXPERIMENTAL

Electrical stimulation and monitoring of the nerves' function.

Device: Neuromonitoring

Interventions

Neuromonitoring DEVICE

Electrical stimulation of the nerve: 1 mA, 4 Hz with surface electromyography of the vocalis muscles.

Also known as: IONM

Neuromonitoring of the EBSLN and RLN

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Jagiellonian University, College of Medicine, Department of Endocrine Surgery, 3rd Chair of General Surgery

Krakow, 31-202, Poland

Location

Related Publications (6)

• 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.

  PMID: 1463114 BACKGROUND

• 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.

  PMID: 1399571 BACKGROUND

• 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.

  PMID: 21181860 BACKGROUND

• 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.

  PMID: 19958945 BACKGROUND

• 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.

  PMID: 11742338 BACKGROUND

• 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.

  PMID: 22402975 DERIVED

MeSH Terms

Conditions

Thyroid Diseases; Goiter

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

• Marcin Barczynski, MD, PhD

  Jagiellonian University, College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: July 15, 2011
• Study Start: September 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 15, 2011

Record last verified: 2011-07

Locations

PL (1)