Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2025-12-29 @ 6:55 AM
Study NCT ID:
NCT05421559
Status:
COMPLETED
Last Update Posted:
2022-06-16
First Post:
2022-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transection of Sternothyroid Muscle Increases the Rate of Exposure of the External Laryngeal Nerve During Thyroidectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013959', 'term': 'Thyroid Diseases'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013965', 'term': 'Thyroidectomy'}], 'ancestors': [{'id': 'D013507', 'term': 'Endocrine Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-13', 'studyFirstSubmitDate': '2022-06-13', 'studyFirstSubmitQcDate': '2022-06-13', 'lastUpdatePostDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of identification and exposure of the external laryngeal nerve during thyroidectomy', 'timeFrame': '1 year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroid', 'Surgery', 'Thyroid Disease']}, 'descriptionModule': {'briefSummary': 'The sternothyroid (ST) muscle is closely adherent to the thyroid gland with oblique insertion into the thyroid cartilage. EBSLN passes through the sternothyroid laryngeal triangle with a parallel course deep to the ST muscle.\n\nThis study evaluates the transection of the sternothyroid muscle as a key step during thyroidectomy to increase the rate of exposure and visual identification of EBSLN compared to ST muscle retraction as a traditional technique.', 'detailedDescription': "The study was conducted on patients eligible for total thyroidectomy, which meets the standard of the ATA Thyroid Guidelines. Preoperative biochemical thyroid function tests and neck ultrasound with FNAC of suspicious nodules confirmed the clinical diagnosis. Patients who had previously undergone neck surgery or irradiation or were preoperatively diagnosed with a vocal cord movement disorder, a vocal cord benign lesion, or speech disorders were excluded from the study. A random number was used to determine the patient group allocation.\n\nData about patients were gathered via history, examinations, and investigations. The patients were randomized (computer-generated) with the use of an opaque-sealed envelope into two groups; group A: conventional method of thyroidectomy with ST muscle retraction, group B: transection of ST muscle.\n\nThe study's primary endpoint was the identification rate of the EBSLN in both techniques. The secondary endpoints included: a comparison of operative time in both techniques as well as anatomical variability of the EBSLN according to Cernea classification, rate of injury of EBSLN, and changes in postoperative voice performance."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* eligible for total thyroidectomy\n* no previous history of neck surgery or radiation\n* no vocal cord pathology\n* no voice disorders\n\nExclusion Criteria:\n\n* not fit for surgery\n* previous history of neck surgery or radiation\n* vocal cord pathology\n* vocal cord movement disorders'}, 'identificationModule': {'nctId': 'NCT05421559', 'briefTitle': 'Transection of Sternothyroid Muscle Increases the Rate of Exposure of the External Laryngeal Nerve During Thyroidectomy', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Transection of Sternothyroid Muscle Increases the Rate of Exposure of the External Branch of the Superior Laryngeal Nerve During Thyroidectomy', 'orgStudyIdInfo': {'id': 'MKSU50-6-9'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conventional approach of thyroidectomy', 'description': 'conventional method of thyroidectomy with ST muscle retraction', 'interventionNames': ['Procedure: thyroidectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'transection approach of thyroidectomy', 'description': 'method of thyroidectomy with ST muscle transection', 'interventionNames': ['Procedure: thyroidectomy']}], 'interventions': [{'name': 'thyroidectomy', 'type': 'PROCEDURE', 'description': 'removal of the diseased thyroid gland by conventional method vs transection method of sternothryroid muscle', 'armGroupLabels': ['conventional approach of thyroidectomy', 'transection approach of thyroidectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33516', 'city': 'Kafr ash Shaykh', 'state': 'Kafr el-Sheikh Governorate', 'country': 'Egypt', 'facility': 'Kafrelsheikh University', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahmed Aouf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr, assistant lecturer of General Surgery', 'investigatorFullName': 'Ahmed Aouf', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}