Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT03577951
Status:
UNKNOWN
Last Update Posted:
2018-09-18
First Post:
2018-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing the Establishment of Operation Space Between High Position and Low Position in Endoscopic Thyroid Surgery
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-17', 'studyFirstSubmitDate': '2018-06-24', 'studyFirstSubmitQcDate': '2018-06-24', 'lastUpdatePostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intercostal arterial bleeding', 'timeFrame': 'During surgery', 'description': 'The number of intercostal artery bleeding'}, {'measure': 'Thyroidectomy time', 'timeFrame': 'During surgery', 'description': 'Time to complete removal of thyroid gland specimens starting from the establishment of the operating space (minutes)'}], 'secondaryOutcomes': [{'measure': 'Thyroid volume', 'timeFrame': 'Before surgery', 'description': 'Thyroid volume calculated by preoperative ultrasound'}, {'measure': "Patient's BMI", 'timeFrame': 'Before surgery', 'description': 'BMI equals body weight divided by height squared'}, {'measure': 'Assessment of skin sensory abnormalities', 'timeFrame': 'two months after surgery', 'description': 'According to the visual scoring method, it was divided into 1-10 points and evaluated by the patient two months after surgery. The score of 10 points was the same as before surgery, and 0 points showed serious discomfort.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroid Cancer', 'Endoscopy']}, 'descriptionModule': {'briefSummary': 'Patients in our department endoscopic thyroidectomy were randomly divided into high position and low position established operating space group established operating space group. The thyroid size, patient BMI, operation time, and intraoperative blood loss were compared between the two groups.', 'detailedDescription': 'Patients in our department endoscopic thyroidectomy were randomly divided into high position and low position established operating space group established operating space group.The sternum angle level is used as the dividing line between the two groups。The thyroid size, patient BMI, operation time, and intraoperative blood loss were compared between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with endoscopic thyroid surgery\n* No previous neck surgery\n\nExclusion Criteria:\n\n* Patients undergoing lateral neck lymph node dissection during the same period'}, 'identificationModule': {'nctId': 'NCT03577951', 'briefTitle': 'Comparing the Establishment of Operation Space Between High Position and Low Position in Endoscopic Thyroid Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Medical University'}, 'officialTitle': 'Comparing the Two Ways of Creating a High Position and Low Position Operating Space in Endoscopic Thyroid Surgery', 'orgStudyIdInfo': {'id': 'Space H and L'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'high position space group', 'description': 'The left and right Trocar meet at the level of the sternum angle and begin to establish the operating space.', 'interventionNames': ['Procedure: high position space group']}, {'type': 'EXPERIMENTAL', 'label': 'low position space group', 'description': 'The left and right Trocar meet under the sternum angle and begin to establish the operating space.', 'interventionNames': ['Procedure: low position space group']}], 'interventions': [{'name': 'high position space group', 'type': 'PROCEDURE', 'description': 'The left and right Trocar meet at the level of the sternum angle and begin to establish the operating space.', 'armGroupLabels': ['high position space group']}, {'name': 'low position space group', 'type': 'PROCEDURE', 'description': 'The left and right Trocar meet under the sternum angle and begin to establish the operating space.', 'armGroupLabels': ['low position space group']}]}, '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}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Bo Wang,MD', 'investigatorAffiliation': 'Fujian Medical University'}}}}