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临床试验/NCT02863484
NCT02863484Unknown4 期

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

Kasr El Aini Hospital1 个研究点 分布在 1 个国家入组 120 人开始时间: 2016年5月1日最近更新:
适应症
干预措施

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

Active Comparator

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

Experimental

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

发起方
Kasr El Aini Hospital
申办方类型
其他
责任方
主要研究者
主要研究者

Ahmed Hegazy

Dr.

Kasr El Aini Hospital

研究点 (1)

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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