Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-01 @ 8:01 PM
Study NCT ID:
NCT06383169
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2024-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of External Drainage of the Lumbar Cistern in Patients With Hydrocephalus Following Meningioma Surgery and Its Influence on Patient Satisfaction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-22', 'studyFirstSubmitDate': '2024-04-22', 'studyFirstSubmitQcDate': '2024-04-22', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of general clinical data', 'timeFrame': '2 weeks'}, {'measure': 'Comparison of the response rate', 'timeFrame': '2 weeks'}, {'measure': 'Comparison of GCS scores and intracranial pressure', 'timeFrame': '2 weeks'}, {'measure': 'Comparison of KPS scores and satisfaction', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Investigate the Effect of External Lumbar Cistern Drainage in Preventing Postoperative Hydrocephalus in Patients Who Have Undergone Meningioma Surgery']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the effect of external lumbar cistern drainage in preventing postoperative hydrocephalus in patients who have undergone meningioma surgery and its impact on patient satisfaction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This retrospective study analysed data from 86 patients who developed postoperative hydrocephalus following meningioma surgery, conducted between May 2019 and May 2022. Based on the inclusion and exclusion criteria, patients were divided into two groups. The control group (n = 43) received conventional treatment methods, and the observation group (n = 43) underwent external drainage of the lumbar cistern.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of meningiomas based on established diagnostic criteria and pathological confirmation\n* postoperative development of hydrocephalus, specifically communicating hydrocephalus\n* absence of other intracranial tumours or contraindications for surgery\n\nExclusion Criteria:\n\n* concurrent mental disorders, coagulation dysfunction or organic diseases affecting other areas\n* hematologic diseases, severe liver or kidney dysfunction\n* patients discontinuing treatment or transferring to a higher-level hospital\n* a history of hydrocephalus, such as obstructive hydrocephalus'}, 'identificationModule': {'nctId': 'NCT06383169', 'briefTitle': 'Impact of External Drainage of the Lumbar Cistern in Patients With Hydrocephalus Following Meningioma Surgery and Its Influence on Patient Satisfaction', 'organization': {'class': 'OTHER', 'fullName': 'First Hospital of Zhangjiakou City'}, 'officialTitle': 'Impact of External Drainage of the Lumbar Cistern in Patients With Hydrocephalus Following Meningioma Surgery and Its Influence on Patient Satisfaction', 'orgStudyIdInfo': {'id': 'wanglizhong'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'observation group'}, {'label': 'control group'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zhangjiakou', 'country': 'China', 'facility': 'First Hospital of Zhangjiakou City', 'geoPoint': {'lat': 40.78341, 'lon': 114.87139}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Hospital of Zhangjiakou City', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}