Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2026-03-01 @ 10:56 AM
Study NCT ID:
NCT03500666
Status:
UNKNOWN
Last Update Posted:
2018-04-18
First Post:
2018-04-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of Robot BABA Approach and Chest Breast Approach for Lateral Neck Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065287', 'term': 'Robotic Surgical Procedures'}], 'ancestors': [{'id': 'D025321', 'term': 'Surgery, Computer-Assisted'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D012371', 'term': 'Robotics'}, {'id': 'D001331', 'term': 'Automation'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-15', 'studyFirstSubmitDate': '2018-04-02', 'studyFirstSubmitQcDate': '2018-04-15', 'lastUpdatePostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lateral cervical lymph node cleaning time', 'timeFrame': 'During surgery', 'description': 'Lateral cervical lymph node clean time from that beginning of cut the SCM leading edge to the end of the specimen'}, {'measure': 'Accessory nerve injury', 'timeFrame': 'During surgery', 'description': 'Accessory nerve injury'}, {'measure': 'Intraoperative internal jugular vein bleeding.', 'timeFrame': '6 months after surgery', 'description': 'Internal carotid vein hemorrhage affect that surgical procedure'}], 'secondaryOutcomes': [{'measure': 'The time of the thyroid gland removal', 'timeFrame': 'During surgery', 'description': 'The time of the thyroid gland removal , including the opening of the white line to the thyroid, and the end of the specimen'}, {'measure': 'Number of participants with HypoParathyroidism', 'timeFrame': '6 months after surgery', 'description': 'The parathyroid function was examined six months after surgery.'}, {'measure': 'Recurrent laryngeal nerve injury.', 'timeFrame': '6 months after surgery', 'description': 'The recurrent laryngeal nerve function due to nerve injury or thermal damage can not be recovered for 6 months.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thyroid carcinoma', 'Robot surgery', 'Endoscopic surgery'], 'conditions': ['Thyroid Carcinoma', 'Robot Surgery', 'Endoscopic Surgery']}, 'descriptionModule': {'briefSummary': 'Objective to compare the advantages and disadvantages of robotic and conventional endoscopic thyroidectomy for thyroid cancer.', 'detailedDescription': 'To compare the difference of operative time and complication between two operative methods in robot neck surgery and routine endoscopic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. papillary thyroid carcinoma with clinically suspected or confirmed lateral lymph node metastasis;\n2. patient's concerns of neck scars and cosmetic requirement.\n\nThe exclusion criteria were as follows:\n\n1\\) tumor size \\>4cm; 2) previous neck surgical history； 3）residual or recurrent tumors; 4) suspicious primary tumor or metastatic lymph node invasion of major vascular structures or recurrent laryngeal nerve.\n\n5）metastatic lymph nodes occurred below the sternoclavicular joint."}, 'identificationModule': {'nctId': 'NCT03500666', 'briefTitle': 'Comparative Study of Robot BABA Approach and Chest Breast Approach for Lateral Neck Dissection', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Medical University'}, 'officialTitle': 'A Comparative Study of Robot Assisted BABA Approach and Chest Breast Approach for Lateral Neck Dissection', 'orgStudyIdInfo': {'id': 'BND and RND'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robot lateral neck lymph node dissection', 'description': 'Robot neck lateral lymph node dissection was performed in patients with thyroid cancer and lateral cervical lymph node metastasis.', 'interventionNames': ['Device: Robot']}, {'type': 'EXPERIMENTAL', 'label': 'Total endoscopic lateral cervical lymph node dissection', 'description': 'Patients with thyroid cancer and lateral cervical lymph node metastases underwent total endoscopic neck dissection.', 'interventionNames': ['Device: Total endoscopic']}], 'interventions': [{'name': 'Robot', 'type': 'DEVICE', 'otherNames': ['Robot lateral neck lymph node dissection'], 'description': 'Robot lateral neck lymph node dissection', 'armGroupLabels': ['Robot lateral neck lymph node dissection']}, {'name': 'Total endoscopic', 'type': 'DEVICE', 'otherNames': ['Total endoscopic lateral cervical lymph node dissection'], 'description': 'Total endoscopic lateral cervical lymph node dissection', 'armGroupLabels': ['Total endoscopic lateral cervical lymph node dissection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350001', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'bo wang, md', 'role': 'CONTACT', 'email': 'wangbo@fjmu.edu.cn', 'phone': '13705947900'}], 'facility': 'Fujian Medical University Union Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '350001', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wen-xin ZHAO, MD', 'role': 'CONTACT', 'email': 'zhaowx@fjmu.edu.cn', 'phone': '8613365910359'}, {'name': 'Bo WANG, MD', 'role': 'CONTACT', 'email': 'wangbo@fjmu.edu.cn', 'phone': '8613705947900'}], 'facility': 'Wen-xin ZHAO', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical professor', 'investigatorFullName': 'Bo Wang,MD', 'investigatorAffiliation': 'Fujian Medical University'}}}}