[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641040":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":12,"centralContacts":40,"locations":46,"responsibleParty":65,"collaborators":12,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":12,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":93,"overallStatus":49,"whyStopped":12,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Charles University, Czech Republic","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Conservative","NO_INTERVENTION","Patients managed without surgical procedures, except for skin sutures.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Interventional","EXPERIMENTAL","Patients undergoing local treatment - lumbar drainage insertion, simple wound puncture, fibrin glue or any combination.",[18,19,20,21],"Procedure: Lumbar Drainage","Procedure: Pseudomeningocele Puncture","Procedure: Puncture with Fibrin Glue Application","Procedure: Revision",[23,28,32,36],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":12},"PROCEDURE","Lumbar Drainage","Insertion of Lumbar drain",[14],{"type":24,"name":29,"description":30,"armGroupLabels":31,"otherNames":12},"Pseudomeningocele Puncture","aspiration of the CSF fluid with injection",[14],{"type":24,"name":33,"description":34,"armGroupLabels":35,"otherNames":12},"Puncture with Fibrin Glue Application","after aspiration of the CSF a fibrin glue is injected into the pseudomeningocele",[14],{"type":24,"name":37,"description":38,"armGroupLabels":39,"otherNames":12},"Revision","Revision surgery in order to prevent future pseudomeninogocele formation",[14],[41],{"name":42,"role":43,"phone":44,"phoneExt":12,"email":45},"Norbert Svoboda, MD, PhD, FEBNS","CONTACT","++420973202932","norbert.svoboda@uvn.cz",[47],{"facility":48,"status":49,"city":50,"state":50,"zip":51,"country":52,"countryCode":12,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Military University Hospital Prague","RECRUITING","Prague","16000","Czechia",{"type":54,"coordinates":55},"Point",[56,57],14.42076,50.08804,{"lat":57,"lon":56},[60,61],{"name":42,"role":43,"phone":44,"phoneExt":12,"email":45},{"name":62,"role":43,"phone":63,"phoneExt":12,"email":64},"Martin Majovsky, MD, Ass. Prof., PhD, FEBNS","+420973202963","martin.majovsky@uvn.cz",{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Norbert Svoboda","Neurosurgeon, Consultant, Head of Department of Cranial Surgery.","100641040","conservative-vs-interventional-management-of-postsurgical-csf-pseudomeningocele-100641040",false,"NCT07614399","Conservative vs Interventional Management of Postsurgical CSF Pseudomeningocele","Conservative Versus Interventional Management of Postsurgical CSF Pseudomeningocele: A Randomized Controlled Trial","PSEUDO","Inclusion Criteria:\n\n* Pseudomeningocele after elective intracranial surgery\n* Willing and able to give informed consent\n* No prior cranial or spinal surgical intervention\n* Pseudomeningocele Palpation Scale (PPS) II-IV, no severe pain of the PMC (VAS 7-10) - Tension MK\n\nExclusion Criteria:\n\n* PMC following emergency or trauma surgery\n* Known or suspected infection at the PMC site at recruitment\n* Severe comorbidities preventing participation (e.g. terminal illness, organ failure)\n* Conditions requiring urgent unrelated surgical intervention",true,"ALL","18 Years","80 Years",{"count":82,"type":83},60,"ESTIMATED","INTERVENTIONAL",[86],"NA","Dear Sir or Madam,\n\nYou have been invited to participate in a clinical study whose aim is to compare the effectiveness of two different approaches to the treatment of cerebrospinal fluid (CSF) pseudomeningocele - conservative management and interventional treatment (surgical or drainage procedures). CSF pseudomeningocele is a complication that may occur after brain surgery and is characterized by an accumulation of cerebrospinal fluid beneath the skin. At present, there is no clear consensus regarding the optimal treatment approach.\n\nHow the study will be conducted\n\nAfter enrollment in the study, you will be randomly assigned (by chance) to one of two groups:\n\nConservative management: no surgical intervention, regular follow-up, and wound care.\n\nInterventional treatment: simple aspiration\u002Fpuncture, insertion of a lumbar drain, or reoperation.\n\nDuring the study, you will be followed for a period of 1 year. Follow-up examinations will include clinical assessment and brain imaging (CT or MRI) at 4 months and 12 months after enrollment.\n\nRisks associated with the interventional group Simple cyst aspiration\u002Fpuncture: infection, bleeding into the pseudomeningocele.\n\nLumbar drainage: infection, meningitis, bleeding at the insertion site, cerebrospinal fluid leakage, nerve root irritation, headaches.\n\nReoperation: bleeding, infection, complications related to general anesthesia. Expected duration of participation in the study\n\n12 months\n\nExpected total number of participants enrolled in the study\n\n20 participants\n\nBenefit of the study\n\nThe aim of the study is to compare the effect of surgical intervention with conservative management.\n\nCompensation for participation\n\nParticipation in this study is not associated with any financial compensation.",[89,90,91,92],"CSF Leak","CSF Pressure Increased","CSF Circulation Disorder","Puncture",[94,95,96],"Cerebrospinal Fluid Leak","Postoperative Complications","Neurosurgery","2026-05-22",{"date":99,"type":100},"2026-05-29","ACTUAL",{"date":102,"type":100},"2025-11-01",{"date":104,"type":83},"2030-11-01",{"name":5,"class":6},1]