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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01395134 |
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Date of registration:
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13/07/2011 |
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Primary sponsor: |
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Public title:
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Visualization Versus Neuromonitoring of the External Branch of the Superior Laryngeal Nerve During Thyroidectomy.
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Scientific title:
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Randomized Controlled Trial of Visualization Versus Neuromonitoring of the External Branch of the Superior Laryngeal Nerve During Thyroidectomy. |
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Date of first enrolment:
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September 2009 |
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Target sample size:
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210 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01395134 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Poland
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Contacts
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Name:
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Marcin Barczynski, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Jagiellonian University, College of Medicine |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Goiter,
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Thyroid,
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Intervention(s)
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Device: Neuromonitoring
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Primary Outcome(s)
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The identification rate of the external branch of the superior laryngeal nerve.
[Time Frame: up to 6 months postoperatively]
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Secondary Outcome(s)
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Anatomical variability of the external branch of the superior laryngeal nerve according to Cernea classification.
[Time Frame: up to 6 months postoperatively]
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The changes in postoperative voice performance.
[Time Frame: up to 6 months postoperatively]
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Secondary ID(s)
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BBN/501/ZKL/1446
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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