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

Sponsor
University Hospital, Brest (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05670860
Collaborator
(none)
700
Enrollment
1
Location
5.9
Anticipated Duration (Months)
117.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    700 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Comitial Prophylaxis in Neurosurgery in Patients Who Have Undergone Intracranial Surgery Programmed Supratentorial Surgery (Exeresis or Biopsy) Between 2019 and 2022
    Actual Study Start Date :
    Nov 22, 2022
    Anticipated Primary Completion Date :
    May 22, 2023
    Anticipated Study Completion Date :
    May 22, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Anti-epileptic prophylaxis

    The first group consists of patients treated between January 2019 and late 2020 who were given systematic prophylaxis
    NO Anti-epileptic prophylaxis

    Patients from the second group were treated between 2021 and 2022 and did not receive any prophylaxis

    Outcome Measures

    Primary Outcome Measures

    1. The number of epileptic seizures during the first postoperative month (between D-0 and D-30) of neurosurgery patients treated for elective supratentorial intracranial procedures. [the first postoperative month (between D-0 and D-30)]

    Secondary Outcome Measures

    1. Commencement of anti-epileptic treatment Length of prophylaxis Treatment's side effects Neurological outcome at 3 and 6 months (RANKIN modified score) [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Brest Brest France 29200

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT05670860
    Other Study ID Numbers:
    • 29BRC22.0198
    First Posted:
    Jan 4, 2023
    Last Update Posted:
    Jan 4, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Brest
    anti-epileptic prophylaxis
    intracranial neurosurgery
    epileptic seizures
    Additional relevant MeSH terms:
    Epilepsy

    Study Results

    No Results Posted as of Jan 4, 2023