Department of Neurosurgery of Medical Univeristy of Warsaw
Warsaw, 02-097, Poland
Location status: Recruiting
NCT Number: NCT07411690
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.
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Request Info18 year and older
All sexes
Observational
Warsaw, 02-097, Poland
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From the enrollment till the end of observation period (6 weeks postoperatively)
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).
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) or resolution of 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.
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.
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.
Total duration and incidence of additional antibiotic therapy in cases of cerebrospinal fluid leak.
Time frame: From the enrollment till the end of observation period (6 weeks postoperatively).
Analysis of techniques utilized for restoration of dural integrity during primary surgical intervention, including: dura suturing, placement of artificial sealants.
Time frame: From the enrollment till the end of observation period (6 weeks postoperatively) or resolution of cerebrospinal fluid leak.
Type of scalp incision during primary surgical intervention (flap or straight line incision).
Time frame: From the enrollment till the end of observation period (6 weeks postoperatively).
Analysis of techniques used for scalp skin closure (continuous absorbable suture or interrupted non-absorbable sutures) during primary surgical intervention.
Time frame: From the enrollment till the end of observation period (6 weeks postoperatively).
Time period between primary surgical intervention and cerebrospinal fluid leak occurrence.
Contact information is provided by the study sponsor or research team.
Medical University of Warsaw
Other
Cerebrospinal Fluid Leak Incidence, Management and Risk Factor After Supratentorial Craniotomy for Intracranial Tumors: a Prospective Observational Study.
Acronym: CSF-IMR
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