New Gentle Biopsy Method of Cervix Lesions Using Superficial Curettage/Protocol ID: CX-CUR
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- pathological comparative results and all cause mobidity
研究概览
简要总结
It is to investigate to what extent a gentle tissue extraction of CIN lesions of the cervix will bring the same conclusion than the conventional cervix biopsy, but with less pain and morbidity, after patients were undergoing a conisation in order to treat CIN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 18 and 80
- •Karnofsky-Index of 80 and higher
- •Cytological suspicious CIN and a colposcopical impression of a major lesion (therapeutical endpoint: conisation)
排除标准
- •Former malign disease oft he pelvic organs
- •Pregnancy
- •Serious internistic diseases
- •Drug addiction
研究组 & 干预措施
gentle tissue extraction (curettage)
Object of this study is the evaluation of two different methods of gaining cervical tissue in order to determine whether, and if so in what extent, a CIN is existent. The first method is a cervical biopsy, the second method is a gentle tissue saving curettage of the cervix uteri. Also is to be investigated that the latter method shows a reduction of pain and morbidity after the procedure.
For this reason the pathological outcome of the two methods will be compared to the result of a conisation, which will be received by the patient to cure their cervical lesions.
干预措施: conventional cervix biopsy (Procedure)
conventional cervix biopsy
Object of this study is the evaluation of two different methods of gaining cervical tissue in order to determine whether, and if so in what extent, a CIN is existent. The first method is a cervical biopsy, the second method is a gentle tissue saving curettage of the cervix uteri. Also is to be investigated that the latter method shows a reduction of pain and morbidity after the procedure.
For this reason the pathological outcome of the two methods will be compared to the result of a conisation, which will be received by the patient to cure their cervical lesions.
干预措施: conventional cervix biopsy (Procedure)
结局指标
主要结局
pathological comparative results and all cause mobidity
时间窗: 1 year
The comparison of these two methods to show that the pathologic diagnostical results are alike and the morbidity is less.
次要结局
未报告次要终点
研究者
Tim Schellenberg
physician
Charite University, Berlin, Germany