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

R

Regional University Hospital Center (CHRU)

Status

Active, not recruiting

Conditions

Anti-epileptic Prophylaxis in Intracranial Neurosurgery

Study type

Observational

Funder types

Other

Identifiers

NCT05670860
29BRC22.0198

Details and patient eligibility

About

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.

Enrollment

700 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adults over 18 years old
  • Expressed non-opposition
  • Patient 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 participate
  • Patient under legal protection

Trial design

700 participants in 2 patient groups

Anti-epileptic prophylaxis
Description:
The first group consists of patients treated between January 2019 and late 2020 who were given systematic prophylaxis
NO Anti-epileptic prophylaxis
Description:
Patients from the second group were treated between 2021 and 2022 and did not receive any prophylaxis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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