Pilot observational study with medications (MOE), single-center, prospective and retrospective study with a group of patients operated on for periventricular lesions and with ventricular entry. As it is an infrequent type of surgery in our centre, the study includes a retrospective group (same surgery and use of TachoSil).~Primary objectives:~The main objective of the study is to evaluate the effectiveness and safety of TachoSil in patients who require ventricular entry.~To evaluate the effectiveness, the percentage of complications related to the ventricular entry during surgery are recorded. These complications are hydrocephalus, CSF leak, meningitis, and pseudomeningocele.~Secondary objectives~Intraoperative incidence of fistula after application of the ventricular patch at 20cm PEEP H20 (efficacy objective).~Incidence of clinically confirmed percutaneous fistula during the first 30 days after surgery (efficacy objective).~Incidence of pseudomeningocele >20cc confirmed with MRI or ultrasound (effectiveness objective).~Incidence of radiologically confirmed hydrocephalus during the first 90 days after of the surgery.~Record the percentage of use of other dural sealants~Evaluate the cost effectiveness of the product.~Describe the adverse effects related to the product~Incidence of complication requiring reintervention within 30 days to the main surgery (safety objective).~Assessment of the complications that are avoided: readmissions.~Study period: from December 2020 to December 2023.
The working hypothesis in this study is that after entering the cerebral ventricular system the sealing with TachoSil is effective and safe.~A more specific hypothesis is that the use of Tachosil for brain surgery with ventricular entry reduces the number of postoperative complications (hydrocephalus, CSF leak, meningitis and pseudomeningocele).