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Brain surgery complication: watchful waiting vs. surgery?

NCT ID NCT07614399

Knowledge-focused Sponsor: Charles University, Czech Republic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at the best way to treat a fluid pocket (pseudomeningocele) that can form under the scalp after brain surgery. It compares doing nothing active (just watching and caring for the wound) with doing a procedure like draining the fluid or another surgery. The goal is to see which approach leads to fewer problems and better recovery over one year.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Nov 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cerebrospinal fluid leak Cerebrospinal Fluid Otorrhea hydrocephalus intracranial hypertension Postoperative Complications

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CSF circulation disorder CSF leak CSF pressure increased Puncture

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Military University Hospital Prague

    RECRUITING

    Prague, Prague, 16000, Czechia

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