NCT02910388已完成不适用
Direct Colposcopic Vision and Large Loop Excision of the Transformation Zone in Women With Cervical Dysplasia: a Randomized Controlled Trial.
Zydolab - Institute of Cytology and Immune Cytochemistry2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- the resected cone mass
研究概览
简要总结
To assess the benefits of large Loop excision of the transformation Zone (LLETZ) under direct colposcopic Vision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •histologically proven cervical dysplasia
- •colposcopy Prior to conization
- •informed consent
排除标准
- •significant language barrier
- •a personal history of conization
- •pregnancy
- •the use of blood thinner
- •unwillingness to participate
结局指标
主要结局
the resected cone mass
时间窗: 10 minutes
the resected cone mass will be quantified by weighing the removed tissue with a precision scale located in the operating room
次要结局
- Operative complications(14 days)
- Intraoperative blood loss(5 hours)
- number of fragments of the surgical specimen(10 minutes)
- satisfaction with the device(30 minutes)
- Margin status(2 Days after conization)
- the dimensions of the surgical specimens(2 Days after conization)
- handling of the device(30 minutes)
- Time to complete intraoperative hemostasis(120 seconds)
- Operation time(20 minutes)
研究者
研究点 (2)
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