Ignite Creation Date:
2025-12-25 @ 4:37 AM
Ignite Modification Date:
2025-12-26 @ 3:39 AM
Study NCT ID:
NCT05216718
Status:
UNKNOWN
Last Update Posted:
2022-01-31
First Post:
2021-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mini-flap BABA (Bilateral Axillo-breast Approach) Robotic Thyroidectomy is Safe
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016606', 'term': 'Thyroid Nodule'}], 'ancestors': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-01-24', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-27', 'studyFirstSubmitDate': '2021-12-30', 'studyFirstSubmitQcDate': '2022-01-27', 'lastUpdatePostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in pain, as measured by the Visual Analog Score(VAS)', 'timeFrame': '2, 24, 48, 72 hours after surgery', 'description': 'Visual Analog Score for pain, range from 0 to 10, Higher the values represents more pains'}, {'measure': 'change from baseline in pain, as measured by the number of analgesics uses', 'timeFrame': '2, 24, 48, 72 hours after surgery', 'description': 'number of analgesics(additional ketorolac uses)'}, {'measure': 'change from baseline in Sensory change, as measured by the monofilaments', 'timeFrame': '1 day before surgery, 1, 3 months after surgery', 'description': 'Six monofilaments were used to measure the pressure threshold of the 2 chest zones and 2 neck zones'}], 'secondaryOutcomes': [{'measure': 'Incidence of vocal cord palsy', 'timeFrame': 'before surgery, 1 day after surgery, 2, 6 weeks after surgery, 6 month, 1year after surgery', 'description': 'Check vocal cord palsy that means injury of the recurrent laryngeal nerve with a direct laryngoscope'}, {'measure': 'change from baseline in Hypoparathyroidism, as measured by parathyroid hormone level', 'timeFrame': 'before surgery, 1 day after surgery, 2, 6 weeks after surgery, 6 month, 1year after surgery', 'description': 'check PTH (parathyroid hormone) level'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mini-flap', 'Bilateral axillo-breast approach', 'Da vinci', 'Robot-assisted thyroid surgery'], 'conditions': ['Thyroid Nodule']}, 'descriptionModule': {'briefSummary': 'In this study, a randomized controlled study was conducted between two groups of 40 recipients of conventional flap during BABA robotic-thyroidectomy and 40 recipients of Mini-flap method during BABA robotic-thyroidectomy. In this study, we tried to determine whether the use of Mini-flap can reduce sensory loss and pain after BABA robotic-thyroidectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects who will have thyroid surgery\n* subjects who has no evidence of lymph node metastasis on palpation and imaging (cN0)\n* subjects who has thyroid nodule under 4cm (\\<cT2)\n* subjects who has no distant metastasis (M0)\n\nExclusion Criteria:\n\n* subjects who has clinical evidence of lymph node metastasis (cN1a or cN1b)\n* subjects who has both thyroid nodule\n* subjects who underwent any radiotherapy on neck\n* subjects who has primary hyperparathyroidism\n* subjects who underwent head and neck surgery\n* subjects who disagree to do this trial'}, 'identificationModule': {'nctId': 'NCT05216718', 'briefTitle': 'Mini-flap BABA (Bilateral Axillo-breast Approach) Robotic Thyroidectomy is Safe', 'organization': {'class': 'OTHER', 'fullName': 'Inje University'}, 'officialTitle': 'Prospective Randomized Controlled Study on Mini-flap Bilateral Axillo-breast Approach Robotic Thyroidectomy : Effect on Postoperative Pain and Sensation', 'orgStudyIdInfo': {'id': '2021-10-014-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conventional flap', 'description': 'BABA robotic-thyroidectomy that using conventional flap', 'interventionNames': ['Procedure: Conventional flap']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mini-flap', 'description': 'BABA robotic-thyroidectomy that using Mini-flap', 'interventionNames': ['Procedure: Mini-flap']}], 'interventions': [{'name': 'Mini-flap', 'type': 'PROCEDURE', 'description': 'Mini-flap BABA robotic-thyroidectomy creates flaps up to the cricoid cartilage', 'armGroupLabels': ['Mini-flap']}, {'name': 'Conventional flap', 'type': 'PROCEDURE', 'description': 'Conventional flap BABA robotic-thyroidectomy creates flaps up to the thyroid cartilage', 'armGroupLabels': ['Conventional flap']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Busan', 'country': 'South Korea', 'facility': 'Dong sik Bae', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inje University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Dongsik Bae', 'investigatorAffiliation': 'Inje University'}}}}