Conservative vs Interventional Management of Postsurgical CSF Pseudomeningocele

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.

Conditions

• CSF Leak
• CSF Pressure Increased
• CSF Circulation Disorder
• Puncture

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

Sponsors & Collaborators

• Charles University, Czech Republic

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-11-01

Primary Completion

2029-11-01

Completion

2030-11-01

Countries

• Czechia

Study Locations