跳至主要内容
临床试验/NCT07315230
NCT07315230尚未招募不适用

Pediatric Midline Post Fossa Tumors Prognostic Factors and Outcomes

Assiut University0 个研究点目标入组 30 人开始时间: 2026年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
Functional Outcome After Surgical Resection of Pediatric Midline Posterior Fossa Tumors

研究概览

简要总结

This study will follow children younger than 18 years with midline posterior fossa brain tumors who undergo standard surgical resection at Assiut University Hospital. The aim is to evaluate functional outcome using the modified Rankin Scale and to explore how tumor type, extent of resection, and perioperative factors are associated with postoperative morbidity and survival. Results may help improve risk stratification and guide individualized treatment strategies for pediatric patients with these tumors.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • patients less than 18 years old
  • patient with midline posterior fossa tumors
  • patient is fit for surgery

排除标准

  • 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.

结局指标

主要结局

Functional Outcome After Surgical Resection of Pediatric Midline Posterior Fossa Tumors

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Hassan Abdelaziz Hassan

Resident at Neurosurgery Department, Assiut University

Assiut University

相似试验