Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-01-09 @ 3:29 PM
Study NCT ID:
NCT04465305
Status:
UNKNOWN
Last Update Posted:
2021-07-08
First Post:
2020-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Controlled Study on the Treatment of Sacral Canal Cysts With Sacral Canal Reinforcement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052958', 'term': 'Tarlov Cysts'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-04', 'studyFirstSubmitDate': '2020-07-06', 'studyFirstSubmitQcDate': '2020-07-06', 'lastUpdatePostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recurrent rate of tarlov cysts', 'timeFrame': '1 year', 'description': 'patents who recurrent postoperation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tarlov cysts surgery'], 'conditions': ['Tarlov Cysts']}, 'descriptionModule': {'briefSummary': 'The subject will treat 68 patients with symptomatic sacral canal cysts as the research object, and adopt a randomized controlled research method, respectively, using two methods of reinforcement and reconstruction of the nerve root sleeve, sacroplasty and nerve root sleeve plasty, and observed the operation of the patient Complications, preoperative and postoperative short-term and long-term VAS pain scores, JOA neural function scores, and changes in cyst size on imaging examinations, to evaluate the safety of nerve root sleeve reconstruction and sacroplasty in reducing the safety of postoperative cyst recurrence Sex and effectiveness, so as to further improve the surgical treatment of sacral canal cysts, improve the curative effect, and formulate the operation specifications for the treatment of sacral canal cyst', 'detailedDescription': 'In this subject, a cohort observation method was used to observe 52 patients with two types of surgical removal of hematoma in the basal ganglia under the guidance of frontal ultrasound through keyhole neuroendoscopy and microsurgery for hematoma removal under the guidance of frontal ultrasound. They were divided into endoscopic surgery group and microsurgery. In the endoscopic surgery group, 26 cases were treated with keyhole neuroendoscopy under the guidance of frontal ultrasound for hematoma removal in the basal ganglia area, and 26 cases in the microsurgery group were treated by craniotomy microsurgery hematoma removal surgery. Observe the removal rate of surgical hematoma in the two groups And the safety of the operation and the GCS score, GOS score and MRI examination of nerve fiber damage and postoperative complications at 1 week, 1 month, and 3 months after the operation. Observe and analyze the improvement of the hematoma clearance rate in the endoscopic surgery group. And whether it has an advantage in terms of efficacy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Symptomatic nerve root cysts diagnosed by MRI\n2. Intact cyst capsule, no defect of sacral canal lamina\n3. No other diseases of nervous system, pelvic floor and important organs\n4. Agree inclusion\n\nExclusion Criteria:\n\na ) Non-radiculent cysts or asymptomatic cysts b) Cysts cause severe bone erosion to lamina resorption c) Combined with other diseases of nervous system, pelvic floor and important organs d) Disagree to join e) Cannot complete follow-up -'}, 'identificationModule': {'nctId': 'NCT04465305', 'acronym': 'ARCSTSCC', 'briefTitle': 'A Randomized Controlled Study on the Treatment of Sacral Canal Cysts With Sacral Canal Reinforcement', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'A Randomized Controlled Study of Nerve Root Sleeve Reinforcement and Reconstruction and Sacral Canopy for the Treatment of Sacral Canal Cysts', 'orgStudyIdInfo': {'id': 'PekingUTHNSD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'enraped group', 'description': 'patients with a new treatment of tarlov cysts', 'interventionNames': ['Procedure: entraped treatment', 'Procedure: plasty treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'plasty group', 'description': 'patients with traditional treatment of tarlov cysts', 'interventionNames': ['Procedure: plasty treatment']}], 'interventions': [{'name': 'entraped treatment', 'type': 'PROCEDURE', 'otherNames': ['plasty treatment'], 'description': 'patients with tarlov cysts treated by entraped and plasty nerve root', 'armGroupLabels': ['enraped group']}, {'name': 'plasty treatment', 'type': 'PROCEDURE', 'description': 'patients with tarlov cysts treated by plasty nerve root', 'armGroupLabels': ['enraped group', 'plasty group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Haidian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'liu bin', 'role': 'CONTACT', 'email': 'liubin301@163.com', 'phone': '13671027688'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'liu bin', 'role': 'CONTACT', 'email': 'liubin301@163.com', 'phone': '13671027688'}, {'name': 'wu chao', 'role': 'CONTACT', 'phone': '82267358', 'phoneExt': '086010'}], 'overallOfficials': [{'name': 'liu bin', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking University Third Hospital'}, {'name': 'wang zhenyu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peking University Third Hospital'}, {'name': 'xie jinchen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Municipal Science & Technology Commission', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}