CSF Circulation Disorder, CSF Leak, CSF Pressure Increased, Puncture
Conditions
Keywords
Cerebrospinal Fluid Leak, Postoperative Complications, Neurosurgery
Brief 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.
Interventions
PROCEDURELumbar Drainage
Insertion of Lumbar drain
PROCEDUREPseudomeningocele Puncture
aspiration of the CSF fluid with injection
PROCEDUREPuncture with Fibrin Glue Application
after aspiration of the CSF a fibrin glue is injected into the pseudomeningocele
PROCEDURERevision
Revision surgery in order to prevent future pseudomeninogocele formation
Sponsors
Charles University, Czech Republic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infection | 12 months | To compare the infection rate between the two treatment groups. |
| Glasgow Outcome Scale Extended (GOSE) | 12 months | To assess functional recovery using the Glasgow Outcome Scale-Extended (GOSE) at 1 year post-surgery. |
| Absorption of the Pseudomeningocoele | 12 months | Absorption of pseudomendingocoele at 4 months and 1 year post-surgery assessed by CT or MRI |
| Pain | 12 months | Persistence of headache after the surgery - Pain Scale 0-10 (VAS) |
Countries
Czechia
Contacts
CONTACTNorbert Svoboda, MD, PhD, FEBNS
Outcome results
None listed