Visualization Versus Neuromonitoring of the External Branch of the Superior Laryngeal Nerve During Thyroidectomy.
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|ClinicalTrials.gov Identifier: NCT01395134|
Recruitment Status : Completed
First Posted : July 15, 2011
Last Update Posted : July 15, 2011
|Condition or disease||Intervention/treatment||Phase|
|Thyroid, Goiter,||Device: Neuromonitoring||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Randomized Controlled Trial of Visualization Versus Neuromonitoring of the External Branch of the Superior Laryngeal Nerve During Thyroidectomy.|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||December 2010|
No Intervention: Visualization of the EBSLN and RLN
Visual inspection of the nerves.
Experimental: Neuromonitoring of the EBSLN and RLN
Electrical stimulation and monitoring of the nerves' function.
Electrical stimulation of the nerve: 1 mA, 4 Hz with surface electromyography of the vocalis muscles.
Other Name: IONM
- The identification rate of the external branch of the superior laryngeal nerve. [ Time Frame: up to 6 months postoperatively ]
- Anatomical variability of the external branch of the superior laryngeal nerve according to Cernea classification. [ Time Frame: up to 6 months postoperatively ]
- The changes in postoperative voice performance. [ Time Frame: up to 6 months postoperatively ]The voice assessment included pre- and postoperative videostrobolaryngoscopy and analysis of maximum phonation time (MPT), voice level (VL), fundamental frequency (Fo), and voice quality rating on GRBAS scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395134
|Jagiellonian University, College of Medicine, Department of Endocrine Surgery, 3rd Chair of General Surgery|
|Krakow, Poland, 31-202|
|Principal Investigator:||Marcin Barczynski, MD, PhD||Jagiellonian University, College of Medicine|