Skull Base Reconstruction After Endonasal Cranio-endoscopic Resection Using Autologus Grafts
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Head CT scan
研究概览
简要总结
Endonasal endoscopic approach to the skull base has been expanded in the last several years owing to advances in the radiological aspect that provided a better evaluation of the lesions and the surrounding structures, technological advances that include angled endoscope, development of high-resolution cameras, high definition monitors and navigation systems and better anatomical experience. The endoscopic endonasal approach now provides access to frontal sinus to the second cervical vertebra in the sagittal plane and from the sella to the jugular foramen in the coronal plane. Endoscopic resection of large skull base tumors results in large defect for which repair is a challenge. Several factors besides the size of the defect should be considered during skull base repair as CSF leak, CSF pressure, history or need for future radiotherapy, lack of support and local tissue vascularity. The aim of this study is to Provide an algorithmic approach for skull base reconstruction after endonasal cranio-endoscopic resection using autologous grafts according to the extent of resection, skull base defect size, the presence of CSF leak, CSF pressure and local tissue vascular
详细描述
Type of the study:
A prospective clinical study will be conducted in the period between January 2018 and January 2020.
Study Setting:
Otolaryngology Department, Alexandria University Hospital. Otolaryngology Department, Assiut University Hospital.
Study tools :
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing endonasal cranio-endoscopic resection
排除标准
- •Unfit patient for surgery.
- •Patient refusal to participate in this study.
结局指标
主要结局
Head CT scan
时间窗: within 1month preoperative
bone window axial, coronal and sagittal cuts to measure preoperative skull base defect size
brain MRI: with and without contrast
时间窗: 6monthes postoperative
Coronal, axial and sagittal MRI in T1 and T2 signals to assess the repaired defect after the surgery, recurrence of tumor
次要结局
- Brain MRI: with and without contrast(within 1 month preoperative)
- the incidence of CSF leakage(within 90 days postoperative)
- type of pathology(within 1 week post operative)
- Endonasal endoscopic evaluation of the grafted defect(within 1 month postoperative, 3monthes postoperative)
- estimation of incidence of sinonasal, orbital &/or intracranial complications(within 90 days following surgery)
- CSF leakage related surgical intervention(within 90 days postoperative)
