Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:25 AM
Study NCT ID:
NCT05670860
Status:
UNKNOWN
Last Update Posted:
2023-01-04
First Post:
2023-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comitial Prophylaxis in Neurosurgery in Patients Who Have Undergone Intracranial Surgery Programmed Supratentorial Surgery (Exeresis or Biopsy) Between 2019 and 2022
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-05-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-02', 'studyFirstSubmitDate': '2023-01-02', 'studyFirstSubmitQcDate': '2023-01-02', 'lastUpdatePostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'timeFrame': 'the first postoperative month (between D-0 and D-30)'}], 'secondaryOutcomes': [{'measure': "Commencement of anti-epileptic treatment Length of prophylaxis Treatment's side effects Neurological outcome at 3 and 6 months (RANKIN modified score)", 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anti-epileptic prophylaxis', 'intracranial neurosurgery', 'epileptic seizures'], 'conditions': ['Anti-epileptic Prophylaxis in Intracranial Neurosurgery']}, 'descriptionModule': {'briefSummary': "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.\n\nWe 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients underwent a supratentorial intracerebral elective surgery (resection or biopsy) over the period from January 01, 2019 to September 01, 2022.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults over 18 years old\n* Expressed non-opposition\n* Patient who underwent supratentorial intracranial surgery (either resection or biopsy) at Brest University Hospital from January 01, 2019 to September 01, 2022.\n\nExclusion Criteria:\n\n* Refusal to participate\n* Patient under legal protection'}, 'identificationModule': {'nctId': 'NCT05670860', 'acronym': 'PRO-CON', 'briefTitle': 'Comitial Prophylaxis in Neurosurgery in Patients Who Have Undergone Intracranial Surgery Programmed Supratentorial Surgery (Exeresis or Biopsy) Between 2019 and 2022', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Comitial Prophylaxis in Neurosurgery in Patients Who Have Undergone Intracranial Surgery Programmed Supratentorial Surgery (Exeresis or Biopsy) Between 2019 and 2022', 'orgStudyIdInfo': {'id': '29BRC22.0198'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anti-epileptic prophylaxis', 'description': 'The first group consists of patients treated between January 2019 and late 2020 who were given systematic prophylaxis'}, {'label': 'NO Anti-epileptic prophylaxis', 'description': 'Patients from the second group were treated between 2021 and 2022 and did not receive any prophylaxis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '29200', 'city': 'Brest', 'country': 'France', 'facility': 'CHU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available beginning three years and ending fifteen years following the final study report completion', 'ipdSharing': 'YES', 'description': 'All collected data that underlie results in a publication', 'accessCriteria': 'Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}