Analysis of Cerebrospinal Fluid Leakage After Surgery for Intracranial Tumors

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical University of Warsaw

About this trial

Cerebrospinal fluid is a clear fluid that surrounds and protects the brain. During surgery for brain tumors, neurosurgeons often need to open the covering of the brain (the dura) to reach the tumor. At the end of the operation, this covering is carefully closed again. In some cases, the closure might not be completely adequate leading to cerebrospinal fluid leak. This leakage may collect under the scalp or flow out through the surgical wound. When this happens, the surgical wound may not heal properly, and the risk of infection can increase. These complications can delay recovery and may postpone additional treatments, such as radiotherapy or chemotherapy, that are often needed after brain tumor surgery. Although cerebrospinal fluid leakage is less common after supratentorial craniotomy (surgery on the upper part of the brain) than after other types of brain surgery, it remains a challenging complication and has not been well studied in this group of patients. The aim of this study is to determine how often cerebrospinal fluid leakage occurs after supratentorial craniotomy for intracranial tumors, identify factors that increase the risk of leakage, and evaluate how these leaks are managed. Understanding these factors may help reduce the occurrence of cerebrospinal fluid leakage and improve postoperative recovery in the future.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female at least 18 years old

Qualified for a craniotomy due to supratentorial intracranial tumor

Disqualifiers

Revision surgery due to recurrent brain tumor

Emergency neurosurgical procedure

Trial population

Patients qualified for supratentorial craniotomy for intracranial tumor.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: Patients qualified for a supratentorial craniotomy for intracranial tumor

Trial outcomes

Primary outcomes

1

Cerebrospinal fluid leakage occurrence.

Any occurrence of cerebrospinal fluid leakage, both internal (fluid accumulating beneath the scalp) and external (fluid draining through the wound margins) will be considered as a primary outcome.

Time frame
From the enrollment till the end of observation period (6 weeks postoperatively)

Secondary outcomes

1

Surgical site infections incidence.

Occurrence of any type of surgical site infections including superficial infections (skin reddening, serous or purulent discharge, wound tissues edema) and deep infections (epidural or subdural empyema, meningitis, brain abscess).

Time frame
From the enrollment till the end of observation period (6 weeks postoperatively).
2

Unplanned outpatient clinic or emergency department visits due to cerebrospinal fluid leak.

Incidence of additional, unplanned outpatient clinic or emergency department visits due to confirmed cases of cerebrospinal fluid leak - both internal and external.

Time frame
From the enrollment till the end of observation period (6 weeks postoperatively) or resolution of cerebrospinal fluid leak.
3

Hospitalization due to cerebrospinal fluid leak.

Incidence of unplanned, additional hospitalizations due to cerebrospinal fluid leak.

Time frame
From the enrollment till the end of observation period (6 weeks postoperatively) or resolution of cerebrospinal fluid leak.
4

Treatment modalities of cerebrospinal fluid leak.

Duration and efficacy of each cerebrospinal fluid leak treatment modality, such as: lumbar drainage, pharmacotherapy (acetazolamide therapy), compressive head dressing, secondary surgical intervention.

Time frame
From the enrollment till the end of observation period (6 weeks postoperatively) or resolution of cerebrospinal fluid leak.

Other outcomes

Sponsors and contacts

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