Comparison Between Surgical Outcomes of Craniotomy and Craniectomy Among Patients with Posterior Fossa Lesion
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Incidence of CSF leakage
研究概览
简要总结
The purpose of this randomized controlled trial is to compare the surgical outcomes of craniotomy and craniectomy among patients with posterior fossa lesions. The study aims to determine differences in post-operative complications, hospital stay duration, and patient recovery between the two surgical techniques.
详细描述
Patients diagnosed with posterior fossa lesions will be randomly assigned into two groups. Group A will undergo craniotomy, where the bone flap is replaced after dural closure, while Group B will undergo craniectomy, where the bone is permanently removed. Outcomes will be assessed based on post-operative complications such as CSF leakage, pseudomeningocele formation, post-operative headache, and length of hospital stay. The study aims to provide evidence to determine the superior surgical approach in terms of patient outcomes and healthcare cost reduction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with posterior fossa lesions
- •Age range: 7-70 years
- •Patients with cerebellar hematoma (traumatic or spontaneous)
排除标准
- •Previous posterior fossa surgery
- •Brainstem hematoma
- •Tumors involving the overlying dura or bone
研究组 & 干预措施
Group A: Craniotomy
This procedure involves creating a single free bone flap using high-speed drills. The bone is repositioned and secured using mini plates or sutures after the surgical intervention is completed. Post-operative monitoring will include assessment for CSF leakage, wound healing, and neurological recovery.
干预措施: Craniotomy (Procedure)
Group B: Craniectomy
In this approach, the bone is removed in pieces using rongeurs, leaving an open dural surface without replacement of the bone. The dura is closed with sutures, and dural augmentation may be performed as needed. Post-operative assessment will focus on complications such as pseudomeningocele, CSF leakage, and extended hospital stays.
干预措施: Craniectomy (Procedure)
结局指标
主要结局
Incidence of CSF leakage
时间窗: Up to 6 months post-surgery
Definition: CSF leakage is defined as the presence of clear fluid discharge from the surgical site, confirmed via clinical examination and biochemical analysis of β-2 transferrin. Measurement: Evaluated by clinical assessment at routine follow-ups and imaging studies when indicated.
Occurrence of pseudomeningocele
时间窗: Up to 6 months post-surgery
Definition: Pseudomeningocele is defined as an abnormal collection of cerebrospinal fluid in the surgical site, detected through physical examination and confirmed by imaging techniques such as MRI or CT scan. Measurement: Follow-up visits at 1, 3, and 6 months post-surgery.
Severity of post-operative headache
时间窗: Immediately post-surgery, at 3 months, and at 6 months post-surgery
Definition: Post-operative headache will be assessed using the Catalano grading system, categorizing severity from 0 (no headache) to 4 (severe, refractory to medication). Measurement: Self-reported patient evaluations at each follow-up visit.
Length of hospital stay
时间窗: From immediate post-surgery until hospital discharge, assessed up to 4 weeks
Definition: The total number of days a patient remains hospitalized post-surgery, including any extended stay due to complications. Measurement: Recorded from hospital admission to discharge.
次要结局
未报告次要终点
研究者
Dr. Birat Thapa Magar
Principal Investigator
University of Health Sciences Lahore