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.
Eligibility
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
