- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07315230
Pediatric Midline Post Fossa Tumors Prognostic Factors and Outcomes
Study Overview
Status
Conditions
Detailed Description
This is a single-center, prospective, hospital-based observational cohort study conducted in the Neurosurgery Department at Assiut University Hospital. Consecutive pediatric patients (<18 years) with radiologically confirmed midline posterior fossa tumors who are considered fit for surgery will be enrolled after informed consent from parents or legal guardians. Preoperative assessment will include demographic data, clinical presentation, neurological examination, and standardized brain MRI.
All patients will undergo surgical resection according to routine neurosurgical practice, using an operating microscope and standard approaches appropriate to tumor location. Intraoperative details (position, approach, estimated blood loss, complications, and surgeon-assessed extent of resection) will be recorded, and tumor specimens will be sent for histopathological diagnosis. Early postoperative evaluation will document Glasgow Coma Scale, intensive care and hospital stay, and complications such as cerebellar mutism, hydrocephalus, and cranial nerve deficits.
Postoperative imaging (CT or MRI) within 48 hours will be used to classify the extent of resection as gross total, near total, subtotal, or partial. Functional outcome will be assessed using the modified Rankin Scale at approximately 6 months after surgery, with patients categorized as having good (mRS 1-3) or poor (mRS 4-6) outcome. Additional follow-up visits (for example at 3 months, 6 months, and annually when feasible) will document tumor recurrence, need for adjuvant therapies, and long-term neurological sequelae.
The main objective is to evaluate functional and radiological outcomes after surgical management of pediatric midline posterior fossa tumors and to identify prognostic factors that influence morbidity, mortality, and quality of life.
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients less than 18 years old
- patient with midline posterior fossa tumors
- patient is fit for surgery
Exclusion Criteria:
- patinent older than 18 years old
- patients with non-midline posterior fossa or other brain tumors.
- patient is unfit for surgery .
- Incomplete Data: Missing essential study data.
- Secondary Malignancy: Metastatic disease.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Outcome After Surgical Resection of Pediatric Midline Posterior Fossa Tumors
Time Frame: 6 months after surgery.
|
Assessment of the patient's functional status using the modified Rankin Scale (mRS) after surgical resection of a midline posterior fossa tumor in children, categorized as good outcome (mRS 1-3) or poor outcome (mRS 4-6).
|
6 months after surgery.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Midline posterior fossa tumors
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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