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Clinical Trials in Czechia / NCT07614399
Recruiting Not applicable

Conservative vs Interventional Management of Postsurgical CSF Pseudomeningocele

NCT07614399 · tracked via the Priya Life Science Czechia tracker
Sponsor
Charles University, Czech Republic
Phase
Not applicable
Started
2025-11-01
Last updated
2026-05-29

Condition(s) studied

CSF LeakCSF Pressure IncreasedCSF Circulation DisorderPuncture

Investigational drug(s) / intervention(s)

Lumbar DrainagePseudomeningocele PuncturePuncture with Fibrin Glue ApplicationRevision

Lumbar Drainage: Insertion of Lumbar drain

Pseudomeningocele Puncture: aspiration of the CSF fluid with injection

Puncture with Fibrin Glue Application: after aspiration of the CSF a fibrin glue is injected into the pseudomeningocele

Revision: Revision surgery in order to prevent future pseudomeninogocele formation

Study summary

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 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.

Risks associated with the interventional group Simple cyst aspiration/puncture: infection, bleeding into the pseudomeningocele.

Lumbar drainage: infection, meningitis, bleeding at the insertion site, cerebrospinal fluid leakage, nerve root irritation, headaches.

Reoperation: bleeding, infection, complications related to general anesthesia. Expected duration of participation in the study

12 months

Expected total number of participants enrolled in the study

20 participants

Benefit of the study

The aim of the study is to compare the effect of surgical intervention with conservative management.

Compensation for participation

Participation in this study is not associated with any financial compensation.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • CSF Leakage or Tension pseudomeningocoele — 12 months
    New-onset wound CSF leakage requiring revision surgery, or pseudomeningocele associated with severe headaches not responsive to analgesics.

Trial sites (1)

FacilityCityRegionStatus
Military University Hospital Prague Prague Prague Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07614399 on ClinicalTrials.gov ↗ ← All trials in Czechia