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Recruiting NCT07614399

Conservative vs Interventional Management of Postsurgical CSF Pseudomeningocele

No phase Interventional CSF Leak CSF Pressure Increased CSF Circulation Disorder Puncture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lumbar Drainage, Pseudomeningocele Puncture, Puncture with Fibrin Glue Application, Revision.
Who it may be relevant to
Registry conditions: CSF Leak, CSF Pressure Increased, CSF Circulation Disorder, Puncture. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Conservative Versus Interventional Management of Postsurgical CSF Pseudomeningocele: A Randomized Controlled Trial

Overview

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.

Interventions

  • Procedure Lumbar Drainage
    Insertion of Lumbar drain
  • Procedure Pseudomeningocele Puncture
    aspiration of the CSF fluid with injection
  • Procedure Puncture with Fibrin Glue Application
    after aspiration of the CSF a fibrin glue is injected into the pseudomeningocele
  • Procedure Revision
    Revision surgery in order to prevent future pseudomeninogocele formation

Primary outcome measures

  • CSF Leakage or Tension pseudomeningocoele [Time frame: 12 months]
Secondary outcome measures (4)
  • Infection [Time frame: 12 months]
  • Glasgow Outcome Scale Extended (GOSE) [Time frame: 12 months]
  • Absorption of the Pseudomeningocoele [Time frame: 12 months]
  • Pain [Time frame: 12 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Czechia · 1 center
  • Military University Hospital Prague — Prague

Identifiers

NCT: NCT07614399 · 108/20-55/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗