CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 210 enrolled
Drug / intervention
Neuromonitoringdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01395134
NCT01395134N/ACompleted
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Randomized Controlled Trial of Visualization Versus Neuromonitoring of the External Branch of the Superior Laryngeal Nerve During Thyroidectomy.

Jagiellonian University·interventional·Posted Jul 15, 2011·Updated Jul 15, 2011

In Brief

A clinical study evaluating Neuromonitoring for Thyroid, and Goiter,. Completed, enrolled 210 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThyroid,, Goiter,
CountriesPoland
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 15, 2011
Enrollment StartSep 1, 2009
Primary CompletionJun 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 15.0 years ago

Interventions

Neuromonitoringdevice

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