Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-02-11 @ 5:15 AM
Study NCT ID:
NCT06161467
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-08
First Post:
2023-09-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcutaneous Laryngeal Ultrasound as an Alternative to Direct Flexible Laryngoscopy in Assessment of Vocal Cords
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-05', 'studyFirstSubmitDate': '2023-09-19', 'studyFirstSubmitQcDate': '2023-12-05', 'lastUpdatePostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vocal cords appearance', 'timeFrame': 'Two years', 'description': 'Assessment of vocal cords appearance by Transcutaneous laryngeal ultrasoungraphy (TLUS) as an alternative to direct flexible laryngoscopy (DFL)'}, {'measure': 'Vocal cords movement', 'timeFrame': 'Two years', 'description': 'Assessment of vocal cords movement by Transcutaneous laryngeal ultrasoungraphy (TLUS) as an alternative to direct flexible laryngoscopy (DFL)'}]}, 'conditionsModule': {'keywords': ['Ultrasound'], 'conditions': ['Ultrasound Therapy; Complications']}, 'referencesModule': {'references': [{'pmid': '19860577', 'type': 'BACKGROUND', 'citation': 'American Thyroid Association (ATA) Guidelines Taskforce on Thyroid Nodules and Differentiated Thyroid Cancer; Cooper DS, Doherty GM, Haugen BR, Kloos RT, Lee SL, Mandel SJ, Mazzaferri EL, McIver B, Pacini F, Schlumberger M, Sherman SI, Steward DL, Tuttle RM. Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer. Thyroid. 2009 Nov;19(11):1167-214. doi: 10.1089/thy.2009.0110.'}, {'pmid': '21044741', 'type': 'BACKGROUND', 'citation': 'Holtel MR. Emerging technology in head and neck ultrasonography. Otolaryngol Clin North Am. 2010 Dec;43(6):1267-74, vii. doi: 10.1016/j.otc.2010.08.003.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the diagnostic value of ultrasound in the assessment of the vocal cords compared with direct flexible laryngoscopy', 'detailedDescription': 'Thyroid and parathyroid surgery are the most common procedures in endocrine surgery worldwide. They are mainly associated with two major complications: recurrent laryngeal nerve (RLN) palsy and hypoparathyroidism, The preservation of recurrent laryngeal nerve (RLN) is an essential part of thyroid surgery {1}. The various methods to test the normal functionality of vocal cords (VCs) include direct visualisation under the fiber bronchoscope, indirect laryngoscopy, laryngeal muscles electromyography, computed tomography (CT), and magnetic resonance imaging (MRI). We aimed to assess the usefulness of ultrasound (USG) in the examination of VC morphology and movement.\n\nRecurrent laryngeal nerve injury ranges from 1.4 to 5.1% following surgery involving the thyroid gland.\n\nOtolaryngology and Head and Neck Surgery suggested that all patients undergoing thyroid and parathyroid procedures should undergo routinely preoperative and postoperative DFL \\[6\\].\n\nLaryngoscopy is considered the golden standard to evaluate vocal fold mobility preoperatively. As it can demonstrate a paralysis of the recurrent laryngeal nerve,. Yet it is not common practice for many endocrine surgery teams because it is time consuming, imposes extra costs, and is in general, an unpleasant experience for some patients.{2} head and neck ultrasonography is a cost effective imaging tool that is currently used as an extension of patient physical examination. That is based on its safety (non invasive and non ionizing radiation dependent), repeatability, availability and good patient compliance (pain less and require no sedation). {3} recently portable ultrasound devices became widely available with dramatic improvement of the imaging quality rendering to increased diagnostic accuracy. Availability, usability and mobility of the devices encourage bedside examination which is essential in non mobile patient and ICU patient \\[4\\] .\n\nHowever, the experience is limited and the reliability of the TLUS in thyroid and parathyroid surgery is still being debated'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for thyroid surgery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for thyroid surgery\n* Patients underwent thyroid surgery\n\nExclusion Criteria:\n\n• Patients with vocal cord paralysis because of any cause other than thyroid surgery complications'}, 'identificationModule': {'nctId': 'NCT06161467', 'briefTitle': 'Transcutaneous Laryngeal Ultrasound as an Alternative to Direct Flexible Laryngoscopy in Assessment of Vocal Cords', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Transcutaneous Laryngeal Ultrasoungraphy (TLUS) as an Alternative to Direct Flexible Laryngoscopy (DFL) in Assessment of Vocal Cords Appearance in Patients Underwent Thyroid Surgery', 'orgStudyIdInfo': {'id': 'vocal cords in US'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ultrasound devices', 'type': 'DEVICE', 'description': 'Safe , no radiation'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Wala Sayed, Student', 'role': 'CONTACT', 'email': 'walazidan898@gmail.com', 'phone': '01095876627'}, {'name': 'Hasan Megaly, Professor', 'role': 'CONTACT', 'email': 'Hassnibrahim48@yahoo.com', 'phone': '01006209584'}], 'overallOfficials': [{'name': 'Amr Farouk, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Supervisor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Walaa Mohamed Ali sayd', 'investigatorAffiliation': 'Assiut University'}}}}