Conservative vs Interventional Management of Postsurgical CSF Pseudomeningocele
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCharles University, Czech Republic
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Lumbar Drainage
Procedure/SurgeryInsertion of Lumbar drain
Pseudomeningocele Puncture
Procedure/Surgeryaspiration of the CSF fluid with injection
Puncture with Fibrin Glue Application
Procedure/Surgeryafter aspiration of the CSF a fibrin glue is injected into the pseudomeningocele
Revision
Procedure/SurgeryRevision surgery in order to prevent future pseudomeninogocele formation
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: ConservativeNo intervention 0 interventions
Group B: InterventionalExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
CSF Leakage or Tension pseudomeningocoele
New-onset wound CSF leakage requiring revision surgery, or pseudomeningocele associated with severe headaches not responsive to analgesics.
Time frame
12 monthsSecondary outcomes
1
Infection
To compare the infection rate between the two treatment groups.
Time frame
12 months2
Glasgow Outcome Scale Extended (GOSE)
To assess functional recovery using the Glasgow Outcome Scale-Extended (GOSE) at 1 year post-surgery.
Time frame
12 months3
Absorption of the Pseudomeningocoele
Absorption of pseudomendingocoele at 4 months and 1 year post-surgery assessed by CT or MRI
Time frame
12 months4
Pain
Persistence of headache after the surgery - Pain Scale 0-10 (VAS)
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov