Conservative vs Interventional Management of Postsurgical... | NCT07614399

Studies
Conservative vs Interventional Management of Postsurgical CSF Pseudomeningocele

NCT07614399

Sponsor

Charles University, Czech Republic

Status

Recruiting

Last Update Posted

May 29, 2026Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

CSF Leak
CSF Pressure Increased
CSF Circulation Disorder
Puncture

Interventions

Lumbar Drainage
Pseudomeningocele Puncture
Puncture with Fibrin Glue Application
Revision

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2025Actual

Primary Completion Date

Nov 1, 2029Estimated

Completion Date

Nov 1, 2030Estimated

First Submitted Date

May 15, 2026

First Submission Date that Met QC Criteria

May 22, 2026

First Posted Date

May 29, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2026

Last Update Posted Date

May 29, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Norbert Svoboda, Neurosurgeon, Consultant, Head of Department of Cranial Surgery., Charles University, Czech RepublicPrincipal Investigator

Lead Sponsor

Charles University, Czech RepublicOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Lumbar Drainage	Procedure	Insertion of Lumbar drain	Interventional

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Infection	To compare the infection rate between the two treatment groups.	12 months
Glasgow Outcome Scale Extended (GOSE)	To assess functional recovery using the Glasgow Outcome Scale-Extended (GOSE) at 1 year post-surgery.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Norbert Svoboda, MD, PhD, FEBNS	Contact	++420973202932		norbert.svoboda@uvn.cz

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Military University Hospital Prague	Recruiting	Prague	Prague	16000	Czechia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 22, 2026	May 22, 2026	Prot_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D002558	Cerebrospinal Fluid Otorrhea
D019586	Intracranial Hypertension
D065634	Cerebrospinal Fluid Leak
D011183	Postoperative Complications

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D006259	Craniocerebral Trauma
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011677	Punctures
D024162	Second-Look Surgery

Ancestor Terms

ID	Term
D013812	Therapeutics
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided