Trial on Intraoperative Neuromonitoring (IONM) in Thyroid Cancer Surgery.

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2019
Scientific objectives: Primary objective: • To assess if the use of IONM can decrease the rates of temporary RLN palsy after thyroid cancer surgery Secondary objectives: * To assess if the use of IONM can decrease permanent RLN palsy rates in patients with thyroid cancers * To assess voice parameters in patients with RLN palsy Methodology: All patients undergoing total thyroidectomy with or without central compartment neck dissection, for thyroid cancers, will be eligible for participation. After confirmation of eligibility and obtaining informed consent, all patients will undergo preoperative screening procedures. Fibreoptic laryngoscopy (FOL) examination will be done to document function of the vocal cords. Preoperative voiceevaluation, GRBAS voice scale assessment and Voice Related Quality of Life (VR-QOL) assessment will be performed for all patients. Patients will then be randomized in a 1:1 ratio to receive IONM or not during surgery. Patients will be stratified as per predefined stratification factors. After surgery, endpoint assessment of vocal cord mobility will be done with a FOL study, by an assessor blinded to the randomization arm. Voice evaluation, GRBAS scale assessment and VR QOL assessment will also be done. An event will be defined as any vocal fold paresis/palsy. Patients without the event will be followed up for 6 months while patients with the event will be followed up for 2 years to assess recovery of vocal cord function and changes in speech parameters. All patients with vocal cord paresis/palsy will be given speech and swallowing rehabilitation
Epistemonikos ID: 904f9843b59a8cde9a9d52da7e22f9d898ac8352
First added on: May 08, 2024