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

NCT01395134 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2011-07-15

No results posted yet for this study

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,

Interventions

DEVICE

Neuromonitoring

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

Sponsors & Collaborators

  • Jagiellonian University

    lead OTHER

Principal Investigators

  • Marcin Barczynski, MD, PhD · Jagiellonian University, College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-06-30
Completion
2010-12-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01395134 on ClinicalTrials.gov