Dissection of the Outer Layer of the Lateral Wall of the Cavernous Sinus Decreases Bleeding as Compared to Direct Tumor Attack in Middle Fossa Meningiomas: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Amount of blood loss as estimated by cubic centimetres during surgery
研究概览
简要总结
The blood loss will be compared in middle fossa meningiomas which will receive pealing of the outer layer of the lateral wall of the cavernous sinus and those which will not revive pealing before the dura is opened
详细描述
Cases with middle fossa meningiomas will be randomised to one of two surgical techniques. The first technique will involve pealing of the outer layer of the lateral wall of the cavernous sinus before the dura is opened and the tumour attacked, and the second group of cases will be operated by a standard technique, where the tumour will be directly attacked with out pealing of the outer layer of the lateral wall of the cavernous sinus. Blood loss will be monitored in each case by calculating the amount of blood in the suction container and subtracting it from the amount of fluids used for irrigation during surgery. The number of cotton patties and dressings will be also counted with each case as well as the number of gauzes used. The pre-operative complete blood picture will be documented particularly the haemoglobin , hematocrits and others. The same lab data will be also monitored after surgery. The amount of blood transfusion required will also be calculated in each case.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 开放(无盲法)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Meningiomas of the middle cranial fossa
排除标准
- Meningiomas outside the middle cranial fossa
研究组 & 干预措施
Conventional surgery intra-dural
This arm will be surgically operated by direct attack of the tumour after opening the dura
干预措施: surgery (Other)
Pealing surgery extra-dural
This arm the pealing of the outer layer of the lateral wall of the cavernous sinus will be done before the dura is opened. After the pealing is completed, the middle meningeal artery will be divided at the foramen spinosum. Then, the dura will be opened and the tumour attacked.
干预措施: surgery (Other)
结局指标
主要结局
Amount of blood loss as estimated by cubic centimetres during surgery
时间窗: three months
次要结局
- Radically of surgery as estimated by post-operative tumour volume in cubic centimetres on post-operative MRI(3 months)
研究者
Ahmed Hegazy
Dr.
Kasr El Aini Hospital
研究点 (1)
标识符
- NCT 编号
- NCT02863484
- 其他研究编号
- N-44-2016
日期
- 首次提交
- (10年前)
- 首次发布
- (10年前)
- 主要完成日期
- (10年前)
- 研究完成日期
- (10年前)
- 最近核实
- (10年前)
- 最近更新
- (10年前)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
