Conservative vs Interventional Management of Postsurgical CSF Pseudomeningocele

NCT07614399 | Recruiting

• 1 other identifier: 108/20-55/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Puncture; CSF Leak; CSF Pressure Increased; CSF Circulation Disorder

Keywords

Cerebrospinal Fluid Leak; Postoperative Complications; Neurosurgery

Outcome Measures

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.

  12 months

Secondary Outcomes (4)

• Infection

  12 months

• Glasgow Outcome Scale Extended (GOSE)

  12 months

• Absorption of the Pseudomeningocoele

  12 months

• Pain

  12 months

Study Arms (2)

Conservative

NO INTERVENTION

Patients managed without surgical procedures, except for skin sutures.

Interventional

EXPERIMENTAL

Patients undergoing local treatment - lumbar drainage insertion, simple wound puncture, fibrin glue or any combination.

Procedure: Lumbar Drainage; Procedure: Pseudomeningocele Puncture; Procedure: Puncture with Fibrin Glue Application; Procedure: Revision

Interventions

Lumbar Drainage PROCEDURE

Insertion of Lumbar drain

Interventional

Puncture with Fibrin Glue Application PROCEDURE

after aspiration of the CSF a fibrin glue is injected into the pseudomeningocele

Interventional

Revision PROCEDURE

Revision surgery in order to prevent future pseudomeninogocele formation

Interventional

Pseudomeningocele Puncture PROCEDURE

aspiration of the CSF fluid with injection

Interventional

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

Military University Hospital Prague

Prague, Prague, 16000, Czechia

RECRUITING

MeSH Terms

Conditions

Cerebrospinal Fluid Otorrhea; Intracranial Hypertension; Cerebrospinal Fluid Leak; Postoperative Complications

Interventions

Punctures; Second-Look Surgery

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Brain Diseases; Central Nervous System Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Norbert Svoboda, MD, PhD, FEBNS

CONTACT

++420973202932; norbert.svoboda@uvn.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgeon, Consultant, Head of Department of Cranial Surgery.

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 29, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2030
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

CZ (1)