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NCT05670860
Comitial Prophylaxis in Neurosurgery in Patients Who Have Undergone Intracranial Surgery Programmed Supratentorial Surgery (Exeresis or Biopsy) Between 2019 and 2022
Conditions: Anti-epileptic Prophylaxis in Intracranial Neurosurgery
Sex: All
Ages: 18 Years – N/A
Enrollment: 700
Sponsor: University Hospital, Brest
Location: France
Summary
JUSTIFICATION Anti-epileptic prophylaxis has long been a systematic practice for supra-tentorial intracranial surgeries.
Since 2021, European guidelines no longer recommend this prophylaxis and practices have evolved.We therefore propose to compare epileptic seizure's occurrence in the first postoperative month between two groups of neurosurgical patients.The first group consists of patients treated between January 2019 and late 2020 who were given systematic prophylaxis.
Patients from the second group were treated between 2021 and 2022 and did not receive any prophylaxis.The secondary objective will consist in identifying the number of patients placed on prophylaxis, the length of prophylaxis, treatment's side effects (depression, elevated liver enzymes…), and comparing patients' neurological outcome at 3 and 6 months after surgical procedures.
Eligibility Criteria
Inclusion Criteria:Adults over 18 years oldExpressed non-oppositionPatient who underwent supratentorial intracranial surgery (either resection or biopsy) at Brest University Hospital from January 01, 2019 to September 01, 2022.Exclusion Criteria:Refusal to participatePatient under legal protection
Source: ClinicalTrials.gov (NCT05670860). StuddyBuddy aggregates publicly available trial information.