Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT05173467
Status:
UNKNOWN
Last Update Posted:
2021-12-30
First Post:
2021-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Robot-assisted Invasion-controlled Surgery Versus Traditional-open Surgery Against Metastatic Spinal Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-12-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2023-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-25', 'studyFirstSubmitDate': '2021-12-13', 'studyFirstSubmitQcDate': '2021-12-25', 'lastUpdatePostDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'operative bleeding', 'timeFrame': 'Intraoperative', 'description': 'It is amount of blood lost during surgery, which is checked by the anesthesiologist and the surgical nurse.'}], 'secondaryOutcomes': [{'measure': 'operation time', 'timeFrame': 'Intraoperative', 'description': 'Is the time from the beginning of the operation to the end of the incision suture is the total operation time'}, {'measure': 'Intraoperative transfusion volume', 'timeFrame': 'Intraoperative', 'description': 'That is the amount of intraoperative red blood cell suspension and plasma input and the incidence of blood transfusion.'}, {'measure': 'Intraoperative fluoroscopy dose', 'timeFrame': 'Intraoperative', 'description': 'The product of intraoperative c-arm fluoroscopy times and single fluoroscopy dose'}, {'measure': 'VAS Scores', 'timeFrame': 'less than 2 years', 'description': 'It isrecorded at1D-3D after surgery (morning, middle and evening assessment every day, in which the most pain of each day was recorded. All patients were standardized to use the same dose of non-steroidal antipyretic and analgesic drugs; if temporary addition of A tablet analgesics was needed, VAS score before use was recorded and the dosage of A tablet was recorded), 2W after surgery, And 3M (long-term postoperative pain)'}, {'measure': 'Frankel Scores', 'timeFrame': 'less than 2 years', 'description': 'The Frankel Scale for Spinal Cord Injury That Classifies the Extent of the Neurological/Functional Deficit into Five Grades'}, {'measure': 'Creatine kinase levels', 'timeFrame': 'less than 2 years', 'description': 'reatine kinase were examined 1 day after operation'}, {'measure': 'myoglobin', 'timeFrame': 'less than 2 years', 'description': 'myoglobin were examined 1 day after operation'}, {'measure': 'Complications', 'timeFrame': 'less than 2 years', 'description': 'Postoperative wound complications were observed during the hospital period, including the incidence of wound infection, wound nonunion, wound debridement, and the frequency of massive bleeding, lung infection, urinary tract infection and other complications'}, {'measure': 'QOL Scores', 'timeFrame': 'less than 2 years', 'description': "Quality of life (QOL) is a multidimensional concept that measures a person's wellbeing."}, {'measure': 'resuming time of daily life', 'timeFrame': 'less than 2 years', 'description': 'Time spent in bed after surgery was recorded'}, {'measure': 'Survival time', 'timeFrame': 'less than 2 years', 'description': 'Survival time'}, {'measure': 'ODI scores', 'timeFrame': 'less than 2 years', 'description': 'The ODI is comprised of 10 questions. The questionnaire asks patients about their ability to manage everyday life and covers intensity of pain, lifting, the ability to care for oneself, ability to walk, the ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Answers are then scored on a 0-5 scale, zero meaning no disability.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Minimal surgery', 'Spinal Metastases', 'invsasion-controlled surgery', 'traditional-open surgery', 'Robot-assisted'], 'conditions': ['Minimally Invasive Surgery', 'Spinal Metastases']}, 'descriptionModule': {'briefSummary': 'With significant advances in diagnostic imaging and systemic therapies for oncologic disease, spinal metastasis with neurological dysfunction and mechanical instability has become an indication for surgery. Even if traditional-open surgery was palliative, the treatment of spinal metastasis also carried significant surgical morbidity. Those high morbidity and complication rates may influence the quality of patients with a limited life expectancy. Invasion-controlled surgery was utilized with Robot-assisted surgery approach against symptomatic spinal metastasis.\n\nIncreasing interest in the potential for improved consistency, complication reduction, and decreased length of hospitalization through robot utilization is evident from the rapid growth of publications seen in recent years.\n\nSo, the investigators wish to evaluate the advantages of Robot-assisted Invasion-controlled Surgery compared with traditional-open surgery spinal surgery in patients with metastatic spinal cord compression.', 'detailedDescription': "Surgical Spinal Decompression of Metastatic Spinal Cord Compression, Minimal Access Versus Open Surgery. A prospective Clinical Trial\n\nPurpose To investigate the effect of Robot-assisted Invasion-controlled Surgery compared with traditional-open surgery in the treatment of patients with metastatic spinalcord compression.\n\nHypotheses The group of patient's receiving robot-assisted invasion-controlled surgery will have better improvement in quality after surgery compared to the group that will receive traditional open surgery. The robot-assisted invasion-controlled surgery group will have reduction in per-operative bleeding and less wound complications compered to the group of patients receiving open or traditional surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Confirmed diagnosis of spinal metastasis (previously confirmed diagnosis of lung cancer, liver cancer, prostate cancer, breast cancer, kidney cancer, digestive tract cancer, imaging indicated the presence of metastatic lesions in the spine)\n2. Patients with symptoms of spinal instability or nerve compression (SINS score of spinal instability ≥7, spinal nerve compression according to spinal cord injury Classification, grade A-D)\n3. Metastases are located in the thoracic and/or lumbar vertebrae\n4. The patient's expected survival was longer than 6 months\n5. The subjects or their legal representatives were able to understand the study purpose, demonstrate adequate compliance with the study protocol, and sign informed consent\n\nExclusion Criteria:\n\n1. He had previously operated on the same site\n2. Spontaneous multiple compression fractures of the spine;\n3. There is malformed osteitis (Paget's bone disease), osteomalacia, or other metabolic bone disease;\n4. here were developmental vertebral malformations or vertebral body and pedicle dysplasia in the spinal segment to be treated by surgery\n5. Presence of heart, lung, liver or kidney failure or other serious diseases (such as osteomyelitis, systemic infection, severe hemorrhagic disease, active disseminated intravascular coagulation, serious cardiovascular disease or myocardial infarction within 6 months prior to enrollment, cerebral infarction within 6 months prior to enrollment, severe psychiatric history)\n6. Pregnant or lactating women\n7. Participated in clinical trials of other drugs or medical devices within 3 months prior to enrollment"}, 'identificationModule': {'nctId': 'NCT05173467', 'briefTitle': 'Robot-assisted Invasion-controlled Surgery Versus Traditional-open Surgery Against Metastatic Spinal Tumor', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Changzheng Hospital'}, 'officialTitle': 'Robot-assisted Invasion-controlled Surgery Versus Traditional-open Surgery Against Metastatic Spinal Tumor', 'orgStudyIdInfo': {'id': '2021SL046'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robot-assisted Invasion-controlled Surgery', 'interventionNames': ['Procedure: Robot-assisted Invasion-controlled Surgery']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Traditional-open Surgery', 'interventionNames': ['Procedure: Traditional-open Surgery']}], 'interventions': [{'name': 'Robot-assisted Invasion-controlled Surgery', 'type': 'PROCEDURE', 'description': 'The concept of invasion-controlled surgery (ICS) for spinal metastasis has been put forward against the spinal instability and neurological dysfunction of frail patients that might not allowed for radical traditional open surgery including improvements of multidisciplinary dynamic assessments, endovascular detachable balloon embolization, minimal-invasion by using expandable working tubes, percutaneous pedicle screws, and some accurate therapy. ICS could provide immediate stability, deformity correction, and recovery of neurological function.', 'armGroupLabels': ['Robot-assisted Invasion-controlled Surgery']}, {'name': 'Traditional-open Surgery', 'type': 'PROCEDURE', 'description': 'This traditionally requires a midline incision, bilateral muscle strip, and multilevel laminectomy to provide adequate access and safe removal of the tumor.', 'armGroupLabels': ['Traditional-open Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200001', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'pengru Wang', 'role': 'CONTACT', 'email': 'wprynl@163.com', 'phone': '18516609786'}], 'facility': 'ChangZheng Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'wei Xu, profession', 'role': 'CONTACT', 'email': 'xuweichangzheng@hotmail.com', 'phone': '13761278657', 'phoneExt': '86-21-81885045'}], 'overallOfficials': [{'name': 'Jianru Xiao, Profession', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai Changzheng Hospital'}, {'name': 'Wei Xu, Profession', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai Changzheng Hospital'}, {'name': 'Bo Li, Profession', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Changzheng Hospital'}, {'name': 'Pengru Wang, Profession', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Changzheng Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wei Xu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Wei Xu', 'investigatorAffiliation': 'Shanghai Changzheng Hospital'}}}}