CompletedNot Applicable

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

Poland210 participantsStarted 2009-09

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: up to 6 months postoperatively

Trial details

NCT IDNCT01395134

SponsorJagiellonian University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-06

View on ClinicalTrials.gov More Thyroid, trials