Conservative vs Interventional Management of Postsurgical CSF Pseudomeningocele
Official title: Conservative Versus Interventional Management of Postsurgical CSF Pseudomeningocele: A Randomized Controlled Trial
Run by Charles University, Czech Republic · NCT07614399 · Data updated 2026-11-12
This study tests whether non-surgical care or a surgical/drainage approach works better for a CSF pseudomeningocele after brain surgery in eligible patients.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Charles University, Czech Republic Academic / other |
| Locations | 1 site (Prague, Prague) |
| Status | Recruiting |
| Started | November 1, 2025 |
| Main results expected | November 1, 2029 |
| Study ends | November 1, 2030 |
| Registry record updated | May 29, 2026 |
| Trial ID | NCT07614399 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with a pseudomeningocele after elective brain surgery, who are willing to consent and have moderate symptomatology without severe comorbidities.
✕Probably not a fit
Patients with infection at the lesion, emergency/trauma-related cases, or significant comorbidity may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional trial compares two management strategies for postsurgical CSF pseudomeningocele: conservative care without surgery versus interventional treatment that may include puncture, lumbar drainage, or revision surgery. Participants are randomly assigned to one of the two groups and followed for one year with clinical assessments and brain imaging. The trial aims to clarify which approach provides better outcomes for patients with a CSF leak after elective intracranial surgery. Enrollment is limited to adults with pseudomeningocele of moderate palpation and no contraindicating conditions. The study is sponsored by Charles University with a site at Military University Hospital Prague.
Why it matters
Potential benefit: If successful, the trial could identify a preferred management strategy that reduces symptoms and complications from postoperative CSF leaks.
How similar studies have gone: Prior research on CSF pseudomeningocele management is limited; this trial tests a direct comparison between conservative and interventional options, with outcomes uncertain.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Military University Hospital Prague
Prague, Prague, Czechia Recruiting
Study contacts
- Study coordinator: Norbert Svoboda, MD, PhD, FEBNS
- Email: norbert.svoboda@uvn.cz
- Phone: ++420973202932
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.