Clinical trial NCT04562077: Role of Surgery in Treatment of Recurrent Brian Glioma:Prognostic Factors and Outcome
Official title: Role of Surgery in Treatment of Recurrent Brian Glioma:Prognostic Factors and Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Recurrent Glioma
Glioma, Malignant
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All cases that fullfill the selection criteria that will be admitted in the department of neurosurgery Assuit university hospital 01/11/2020 to 30/10/2021.

Sample size was calculated using Epi- Info7. The previous study reported that, percentage of complications after re-operation in recurrent glioma was 65%. Based on this percentage and with a confidence limits of 10% and a confidence level of 80%, the minimum sample needed for the study was estimated to be 20 patients.

Patients whose follow-ups will be lost because of death or any other cause will be excluded from this study (expected to be 25%). Additionally, the competence of follow-up will be approved by imaging and medical records.

Brief summary: role of surgery in treatment of recurrent brain glioma prognostic factors and outcome measures Role of surgery : In patients with Grade I gliomas, such as pilocytic astrocytomas, resection is potentially curative.

For more diffuse invasive gliomas (Grade II or higher), initial management typically includes maximal safe resection when possible.

Increasing evidence supports an association between extent of resection and prolonged progression-free and overall survival for patients with diffuse gliomas of all types and grades Many studies reported that more that 90%of patients with glioma showed recurrence at the orginal tumor location.

Review the outcomes of re-operation in treatment of recurrent brain gliomas To determine the prognostic factors which can predict which patient would benefit from multiple surgery .

Trail to Improve the outcome of these patients and decrease rate of complications


Eligibility criteria: Inclusion Criteria:

- Patient previously operated and documented as a glioma with clinical and neuroimaging and pathological evidences.

Patients who will undergo re-operation for treatment of a recurrent brain glioma at the time of study(one year) Histological types : Different histological types of glioma.

Exclusion Criteria:

* patients has brain glioma that is de novo patients who are unfit for any neurosurgical interventions. Multicentric recurrent glioma.

Primary outcomes:
measure: karnofsky performance status
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit University Hospitals
Study officials:
affiliation: professor of neurosurgery assiut university
name: Ahmed AlGhriany, phD
role: STUDY_DIRECTOR
affiliation: assistant professor of neurosurgery assiut university
name: Ahmed AlShanawany, phD
role: STUDY_DIRECTOR
affiliation: Resident at department of neurosurgery
name: Mohamad S Waer
role: PRINCIPAL_INVESTIGATOR
References: