protocolSection identificationModule nctId: NCT06289309, orgStudyIdInfo id: N41/DBS/001142, briefTitle: NerveTrend vs. NerveAssure in Prevention of Recurrent Laryngeal Nerve Injury During Thyroid Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Marcin Barczynski, class: OTHER, descriptionModule briefSummary: The aim of this study is to compare two distinct modes of NIM Vital application in thyroid surgery: NerveTrend vs. NerveAssure mode with respect to prevalence of early postoperative RLN injury.The hypothesis explored in this study is that NerveTrend mode may be not inferior than NerveAssure mode in intraoperative identification of impending neural injury and in prognostication of postoperative glottis function in monitored bilateral thyroid surgery. Hence, NerveTrend mode may be considered a bridge between i-IONM and NerveAssure modes, and particularly in health care environments with limited financial resources it can be considered a substantial step forward representing a modern alternative to the NerveAssure technique.A prospective, randomized study with 2 arms: NeveTrend vs. NerveAssure mode (n=132 patients and 264 nerves at risk, each).The primary outcome measure is prevalence of recurrent laryngeal nerve (RLN) injury (%) on postoperative day 1 assessed by direct laryngoscopy., conditionsModule conditions: Thyroid Diseases, conditions: Surgery, conditions: Recurrent Laryngeal Nerve Injuries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A prospective, randomized study with 2 arms: NeveTrend vs. NerveAssure mode (n=132 patients and 264 nerves at risk, each). Patients referred to the Department of Endocrine Surgery, Jagiellonian University Medical College in Krakow, for first-time thyroid surgery from March 1, 2024 onwards will be registered. Eligible patients with either benign or malignant thyroid disease will be assessed for the study. The study protocole has been approved by the Institutional Review Board (Bioethics Committee of the Jagiellonian University)., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: Both participants and outcomes assessor will be blinded to the respective group assignment., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 264, type: ESTIMATED, armsInterventionsModule interventions name: Neuromonitoring of the recurrent laryngeal nerves, outcomesModule primaryOutcomes measure: Prevalence of recurrent laryngeal nerve injury (%) assessed by direct laryngoscopy, secondaryOutcomes measure: Positive predictive value (%) of introperative neuromonitoring of recurrent laryngeal nerves in prognostication of postoperative glottis function assessed by direct laryngoscopy, secondaryOutcomes measure: Negative predictive value (%) of introperative neuromonitoring of recurrent laryngeal nerves in prognostication of postoperative glottis function assessed by direct laryngoscopy, secondaryOutcomes measure: Prevalence of permanent recurrent laryngeal nerve injury (%) assessed by direct laryngoscopy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Endocrine Surgery, Jagiellonian University College of Medicine, status: RECRUITING, city: Krakow, zip: 31-202, country: Poland, contacts name: Marcin Barczynski, MD, PhD, role: CONTACT, phone: +48602375939, email: marbar@mp.pl, contacts name: Marcin Barczynski, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.06143, lon: 19.93658, hasResults: False