Anti-epileptic Prophylaxis in Intracranial NeurosurgeryPRO-CONNCT05670860
Comitial Prophylaxis in Neurosurgery in Patients Who Have Undergone Intracranial Surgery Programmed Supratentorial Surgery (Exeresis or Biopsy) Between 2019 and 2022
An observational study of Anti-epileptic Prophylaxis in Intracranial Neurosurgery, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anti-epileptic Prophylaxis in Intracranial Neurosurgery
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2022to 22 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients underwent a supratentorial intracerebral elective surgery (resection or biopsy) over the period from January 01, 2019 to September 01, 2022.
Who may be able to join
- 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.
Who cannot join
- Refusal to participate
- Patient under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Keywords
- anti-epileptic prophylaxis, intracranial neurosurgery, epileptic seizures
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: the first postoperative month (between D-0 and D-30)
Secondary outcomes (1)
Commencement of anti-epileptic treatment Length of prophylaxis Treatment's side effects Neurological outcome at 3 and 6 months (RANKIN modified score)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start22 Nov 2022
- Primary completion22 May 2023 (estimated)
- Study completion22 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-epileptic Prophylaxis in Intracranial NeurosurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670860
- Sponsor's protocol ID
- 29BRC22.0198
- Acronym
- PRO-CON
- Status last verified
- Jan 2023
- First submitted
- 2 Jan 2023
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comitial Prophylaxis in Neurosurgery in Patients Who Have Undergone Intracranial Surgery Programmed Supratentorial Surgery (Exeresis or Biopsy) Between 2019 and 2022
- ClinicalTrials.gov ID
- NCT05670860
- Acronym / sponsor ID
- PRO-CON / 29BRC22.0198
- Keywords
- anti-epileptic prophylaxis, intracranial neurosurgery, epileptic seizures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 22 May 2023 (estimated)
- Study completion
- 22 May 2023 (estimated)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients underwent a supratentorial intracerebral elective surgery (resection or biopsy) over the period from January 01, 2019 to September 01, 2022.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Refusal to participate
- Patient under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: the first postoperative month (between D-0 and D-30)
1 secondary outcome
Commencement of anti-epileptic treatment Length of prophylaxis Treatment's side effects Neurological outcome at 3 and 6 months (RANKIN modified score)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anti-epileptic Prophylaxis in Intracranial Neurosurgery, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: the first postoperative month (between D-0 and D-30)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.