Endocervical Evaluation With the Curette Versus Cytobrush for the Diagnosis of Dysplasia of the Uterine Cervix
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 主要终点
- Specimen adequacy
研究概览
简要总结
OBJECTIVE: to compare endocervical brushing with endocervical curettage with respect to diagnostic and patient discomfort.
METHOD: women referred to colposcopy because of abnormal Papanicolaou tests will be randomized to endocervical sampling with either a metal curette (endocervical curettage -ECC) or and endocervical brush. All samples will be submitted for histological study.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •French-speaking
- •21 years or older
- •Attending our colposcopy clinic
- •Need for endocervical evaluation
- •Full autonomy or capacity to understand the procedures
排除标准
- •Pregnancy
- •Absence of uterus
- •History of DES exposure in utero
结局指标
主要结局
Specimen adequacy
时间窗: 09/2011 - 05/2012 (1 year)
Cytological and histological interpretation of the endocervical brush specimens will then be performed, while for the endocervical currete specimens only histological interpretation will be done. The adequacy of the specimens will be based on the quantity of endocervical cells present (\< or ≥ 20 endocervical cells), the quantity of histological material (\< or ≥ 3 epithelial stripes) and the quality of histological material (absence or presence of lamina propia).
次要结局
- Patient discomfort(09/2011 to 05/2012 (8 months))
研究者
Manuela Undurraga Malinverno
Medecin Interne
University Hospital, Geneva