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Conservative vs Interventional Management of Postsurgical CSF Pseudomeningocele

RecruitingNAAges 18 Years - 80 YearsAllCharles University, Czech Republic
NCT07614399 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Dear Sir or Madam, You 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. How the study will be conducted After enrollment in the study, you will be randomly assigned (by chance) to one of two groups: Conservative management: no surgical intervention, regular follow-up, and wound care. Interventional treatment: simple aspiration/puncture, insertion of a lumbar drain, or reoperation. During the study, you will be followed for a

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📋 Eligibility rules (as published)
Inclusion Criteria: * Pseudomeningocele after elective intracranial surgery * Willing and able to give informed consent * No prior cranial or spinal surgical intervention * Pseudomeningocele Palpation Scale (PPS) II-IV, no severe pain of the PMC (VAS 7-10) - Tension MK Exclusion Criteria: * PMC following emergency or trauma surgery * Known or suspected infection at the PMC site at recruitment * Severe comorbidities preventing participation (e.g. terminal illness, organ failure) * Conditions requiring urgent unrelated surgical intervention
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What it tests

  • Lumbar Drainage
  • Pseudomeningocele Puncture
  • Puncture with Fibrin Glue Application
  • Revision
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Where

1 site
Military University Hospital Prague
Prague, Czechia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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