Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-02 @ 1:10 PM
Study NCT ID:
NCT04541758
Status:
UNKNOWN
Last Update Posted:
2021-01-20
First Post:
2020-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing the Efficacy of Conservative Treatment With Minimally Invasive Surgery in the Treatment of Rib Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013898', 'term': 'Thoracic Injuries'}, {'id': 'D012253', 'term': 'Rib Fractures'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000072700', 'term': 'Conservative Treatment'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 238}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-17', 'studyFirstSubmitDate': '2020-08-15', 'studyFirstSubmitQcDate': '2020-09-07', 'lastUpdatePostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage improvement of lung function FEV1(Forced expiratory volume in one second)', 'timeFrame': 'FEV1%(One week after treatment)-FEV1%(Admitted)', 'description': 'FEV1(Forced expiratory volume in one second)，FEV1% ：percentage of the expected value'}], 'secondaryOutcomes': [{'measure': 'Percentage improvement of lung function FVC', 'timeFrame': 'FVC%(One week after treatment)-FVC%(Admitted)', 'description': 'FVC（forced vital capacity），FVC%：percentage of the expected value'}, {'measure': 'Percentage improvement of lung function PEF', 'timeFrame': 'PEF%(One week after treatment)-PEF%(Admitted)', 'description': 'PEF（peak expiratory flow ），PEF%：percentage of the expected value'}, {'measure': 'Pain index', 'timeFrame': 'Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year', 'description': 'visual analogue scale，VAS（0-10）0：no pain；10：severe pain'}, {'measure': 'Pleural effusion', 'timeFrame': 'Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year', 'description': 'Measured by chest CT'}, {'measure': 'Mortality rate', 'timeFrame': 'Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year', 'description': 'Deaths associated with this study'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year', 'description': 'Length of hospital stay'}, {'measure': 'Cost of treatment', 'timeFrame': 'One year', 'description': 'Sum of all treatment costs'}, {'measure': 'Chronic pain', 'timeFrame': 'Three month after treatment;Half a year;One year', 'description': 'Pain lasting more than three months（It is suggested in the related article that pain lasting more than 3 months is chronic pain）visual analogue scale，VAS（0-10）0：no pain；10：severe pain'}, {'measure': 'Quality of Life score', 'timeFrame': 'One week after treatment；One month after treatment;Three month after treatment;Half a year;One year', 'description': 'The Barthel index of ADL'}, {'measure': 'Time to resume routine work', 'timeFrame': 'One week after treatment；One month after treatment;Three month after treatment;Half a year;One year', 'description': 'Time to resume routine work'}, {'measure': 'Duration of analgesic medication', 'timeFrame': 'intraoperative；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year', 'description': 'Duration of analgesic medication'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rib fractrue;surgical treatment;Rapid recovery'], 'conditions': ['Chest Trauma', 'Rib Fractures', 'Surgery--Complications']}, 'descriptionModule': {'briefSummary': 'Open, randomized, parallel controlled prospective clinical study design was used in this study.Subjects were patients with 2-4 displaced non-flail rib fractures.Operation group (Group 1) : minimally invasive internal fixation operation group under spontaneous breathing anesthesia.In the operation group of minimally invasive internal fixation under autonomic respiratory anesthesia, the fracture was determined preoperatively by chest CT+ three-dimensional reconstruction of the ribs, and the optimal incision location was determined. The fracture was exposed through as many small incisions as possible, and fixed with titanium plate or clon-type plate. During the operation, the autonomic respiratory anesthesia and paraviral nerve block technology was adopted.In the conservative group (group 2), routine treatment measures such as analgesia and chest strap fixed were adopted.The purpose of this study was to evaluate the safety, feasibility, and efficacy of minimally invasive and conservative treatment for rib fractures with different Numbers of displaced ends.', 'detailedDescription': 'An open, randomized, parallel controlled prospective clinical study design type was used in this study. Subjects were patients with two to four displaced non-flail chest fractures of the ribs. Operation group (Group 1) : minimally invasive internal fixation operation group under spontaneous breathing anesthesia. In the operation group of minimally invasive internal fixation under autonomic respiratory anesthesia, the fracture was determined preoperatively by chest CT+ three-dimensional reconstruction of the ribs, and the optimal incision location was determined. The fracture was exposed through as many small incisions as possible, and fixed with titanium plate or clon-type plate. During the operation, the autonomic respiratory anesthesia and paraviral nerve block technology was adopted. In the conservative group (group 2), routine treatment measures such as analgesia, hemostasis and chest band fixation were adopted. The effects of the two treatments on lung function, pain index, complications and QoL were evaluated. It provides theoretical basis for the treatment of rib fracture'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Unilateral thoracic trauma, fractured ends of rib fractures displaced 2-4 places\n2. Displaced fracture（CT image shows double displacement of bone cortex） located in the 3rd to 10th rib\n3. The number of broken ends of displaced fractures is greater than that of undisplaced fractures\n4. The length of time from injury to hospitalization \\<24 hours\n5. Age range（18-70）\n6. ASA grade I-II\n7. BMI \\< 30\n8. Preoperative partial arterial oxygen pressure \\>60mmHg, partial arterial carbon dioxide pressure \\<50mmHg\n\nExclusion Criteria:\n\n1. Difficult airway\n2. History of esophageal reflux\n3. Myasthenia gravis\n4. Abnormal coagulation system\n5. History of gastrointestinal ulcer or bleeding\n6. History of anaesthesia related drug allergy\n\nA history of asthma or chronic obstructive emphysema\n\n8\\. Women during pregnancy\n\n9\\. Flail chest\n\n10\\. Combined with severe craniocerebral trauma and external abdominal injuries\n\n11\\. Recent use of clopidogrel, warfarin and aspirin seriously affects blood clotting\n\n12\\. Self-administered analgesics after injury\n\n13.Massive hemopneumothorax requires emergency surgery\n\n14\\. Patients who cannot tolerate surgery\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04541758', 'briefTitle': 'Comparing the Efficacy of Conservative Treatment With Minimally Invasive Surgery in the Treatment of Rib Fractures', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 6th People's Hospital"}, 'officialTitle': 'Comparing the Efficacy of Conservative Treatment With Minimally Invasive Surgery in the Treatment of 2-4 Displaced Rib Fractures:A Prospective Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'ynlc201908'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'surgical treatment', 'description': 'Minimally invasive internal fixation under spontaneous respiratory anesthesia and analgesic treatment and chest strap fixation', 'interventionNames': ['Procedure: surgical treatment', 'Procedure: Conservative treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Conservative treatment', 'description': 'analgesic treatment and chest strap fixation', 'interventionNames': ['Procedure: Conservative treatment']}], 'interventions': [{'name': 'surgical treatment', 'type': 'PROCEDURE', 'description': 'surgical treatment and Conservative treatment', 'armGroupLabels': ['surgical treatment']}, {'name': 'Conservative treatment', 'type': 'PROCEDURE', 'description': 'Conservative treatment', 'armGroupLabels': ['Conservative treatment', 'surgical treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yang Li, PHD', 'role': 'CONTACT', 'email': 'drliyang1991@163.com', 'phone': '13122109923'}], 'overallOfficials': [{'name': 'Yi Yang, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Shanghai 6th People's Hospital"}, {'name': 'Zongli Gao, PHD', 'role': 'STUDY_CHAIR', 'affiliation': "Shanghai 6th People's Hospital"}, {'name': 'Yonghong Zhao, PHD', 'role': 'STUDY_CHAIR', 'affiliation': "Shanghai 6th People's Hospital"}, {'name': 'Weiming Wu, PHD', 'role': 'STUDY_CHAIR', 'affiliation': "Shanghai 6th People's Hospital"}, {'name': 'Weigang Zhao, PHD', 'role': 'STUDY_CHAIR', 'affiliation': "Shanghai 6th People's Hospital"}, {'name': 'Tiancheng Zhao, PHD', 'role': 'STUDY_CHAIR', 'affiliation': "Shanghai 6th People's Hospital"}, {'name': 'Xiang Guo, PHD', 'role': 'STUDY_CHAIR', 'affiliation': "Shanghai 6th People's Hospital"}, {'name': 'Lei Wang, PHD', 'role': 'STUDY_CHAIR', 'affiliation': "Shanghai 6th People's Hospital"}, {'name': 'Weiwei He, PHD', 'role': 'STUDY_CHAIR', 'affiliation': "Shanghai 6th People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data will not be Shared with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 6th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Li Yang', 'investigatorAffiliation': "Shanghai 6th People's Hospital"}}}}