Analysis of Cerebrospinal Fluid Leakage After Surgery for Intracranial Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Brain Tumor Adult, Brain Tumor Benign, CerebroSpinal Fluid (CSF) Leak, Craniotomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cerebrospinal Fluid Leak Incidence, Management and Risk Factor After Supratentorial Craniotomy for Intracranial Tumors: a Prospective Observational Study.
Overview
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.
Detailed description
Cerebrospinal fluid is a fluid that circulates within the subarachnoid space between the brain surface and the meningeal layers, providing mechanical protection and metabolic support to the central nervous system. During neurosurgical procedures for intracranial tumors, opening of the meningeal layers, including the dura mater, is routinely required to access deeper cerebral structures. At the conclusion of surgery, meticulous dural closure is performed to restore a watertight barrier. However, in certain cases, dural reconstruction may be insufficient, resulting in postoperative cerebrospinal fluid leakage.
Cerebrospinal fluid leakage may manifest as accumulation of fluid beneath the scalp tissues or as external drainage through the surgical wound margins. The presence of cerebrospinal fluid leakage compromises normal wound healing and increases the risk of postoperative complications, including superficial and deep surgical site infections. These complications may delay wound healing, prolong hospitalization, and affect the timing of postoperative adjuvant therapies such as radiotherapy or chemotherapy in patients with intracranial tumors. Although cerebrospinal fluid leakage is more commonly associated with infratentorial procedures, it remains a significant and challenging complication following supratentorial craniotomy. Despite its clinical relevance, cerebrospinal fluid leakage after supratentorial tumor surgery is relatively under investigated, and data regarding its incidence, risk factors, and optimal management strategies remain limited. This prospective observational study aims to evaluate the incidence of cerebrospinal fluid leakage following supratentorial craniotomy for intracranial tumors, identify patient and surgery related risk factors, and assess the effectiveness of various management and treatment modalities. All patients undergoing supratentorial craniotomy for intracranial tumor resection will be prospectively observed, and those who develop postoperative cerebrospinal fluid leakage will be identified and analyzed. Data collection will include tumor related anatomical characteristics, dural closure techniques, materials used for dural reconstruction, and therapeutic interventions employed for the management of cerebrospinal fluid leakage. Patients will be followed for a period of six weeks postoperatively, corresponding to the typical timeframe for initiation of adjuvant oncological treatment. The findings of this study aim to improve understanding of cerebrospinal fluid leakage in supratentorial craniotomies and may contribute to the development of strategies to reduce its incidence and associated complications in the future.
Primary outcome measures
- Cerebrospinal fluid leakage occurrence. [Time frame: From the enrollment till the end of observation period (6 weeks postoperatively)]
Secondary outcome measures (9)
- Surgical site infections incidence. [Time frame: From the enrollment till the end of observation period (6 weeks postoperatively).]
- Unplanned outpatient clinic or emergency department visits 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.]
- Hospitalization 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.]
- Treatment modalities of cerebrospinal fluid leak. [Time frame: From the enrollment till the end of observation period (6 weeks postoperatively) or resolution of cerebrospinal fluid leak.]
- Antibiotic therapy. [Time frame: From the enrollment till the end of observation period (6 weeks postoperatively) or resolution of cerebrospinal fluid leak.]
- Dura restoration techniques. [Time frame: From the enrollment till the end of observation period (6 weeks postoperatively).]
- Scalp incision type. [Time frame: From the enrollment till the end of observation period (6 weeks postoperatively) or resolution of cerebrospinal fluid leak.]
- Skin closure techniques. [Time frame: From the enrollment till the end of observation period (6 weeks postoperatively).]
- Cerebrospinal fluid leak occurrence timing. [Time frame: From the enrollment till the end of observation period (6 weeks postoperatively).]
Eligibility criteria
Inclusion criteria
- Male or female at least 18 years old
- Qualified for a craniotomy due to supratentorial intracranial tumor
Exclusion criteria
- Revision surgery due to recurrent brain tumor
- Emergency neurosurgical procedure
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Poland · 1 center
- Department of Neurosurgery of Medical Univeristy of Warsaw — Warsaw
Identifiers
NCT: NCT07411690 · KB/147/2025