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临床试验/NCT03448614
NCT03448614Unknown不适用

Skull Base Reconstruction After Endonasal Cranio-endoscopic Resection Using Autologus Grafts

Assiut University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年1月1日最近更新:
适应症

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

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)

研究者

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

Ahmed Gamal Sholkamy

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Assiut University

研究点 (1)

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