Management of Cervical Intraepithelial Neoplasia Grade 2
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- 43 women in the follow-up group, 44.1% experienced spontaneous regression, 20.9% had partial regression, 23.2% progressed to CIN3, and 11.6% showed persistence. 44 women whose lesion was excised, the regression rate was 90.9%
研究概览
简要总结
The aim of this study was to compare two management options for CIN 2. This randomized clinical trial performed between 2003 and 2006. A series of 90 Brazilian women diagnosed as CIN2 were randomized into two groups: 1) 45 whose lesion was excised and,2) 45 women subjected to follow-up at 3-month intervals for 12 months.
详细描述
Pap smear and colposcopy were performed at every follow-up visit and all lesions were completely visible at colposcopy.
The researchers purpose was to make some comments about the over treatment and the misclassification of CIN 2.
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 61 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histological CIN2 diagnosis
排除标准
- •Previous CIN treatment
结局指标
主要结局
43 women in the follow-up group, 44.1% experienced spontaneous regression, 20.9% had partial regression, 23.2% progressed to CIN3, and 11.6% showed persistence. 44 women whose lesion was excised, the regression rate was 90.9%
时间窗: 12 months
次要结局
未报告次要终点