NCT05670860

Comitial Prophylaxis in Neurosurgery in Patients Who Have Undergone Intracranial Surgery Programmed Supratentorial Surgery (Exeresis or Biopsy) Between 2019 and 2022

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 700 (actual)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Anti-epileptic Prophylaxis in Intracranial Neurosurgery

Timeline

• Start date: 2022-11-22
• Primary completion: 2023-05-22
• Completion: 2023-05-22
• First posted: 2023-01-04
• Last updated: 2023-01-04

Locations

1 site across 1 country: France