NCT02486471已完成不适用
Is a Hemostatic Procedure Required After Biopsy of the Cervix Uteri in Women Undergoing Colposcopy for Cervical Dysplasia? A Multicenter Randomized Non-inferiority Trial
Zydolab - Institute of Cytology and Immune Cytochemistry4 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2015年7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
- 166
- 试验地点
- 4
- 主要终点
- Blood loss after 15 minutes (5-step visual analogue scale)
研究概览
简要总结
Cytological abnormalities of the Cervix uteri need to be clarified by colposcopy biopsy. To avoid bleeding after biopsy, monsel´s paste is a common used Agent. In a randomized clinical Trial the use of monsel´s paste after biopsy will be compared to no Intervention. The Primary outcome of the study is blood loss, secondary outcomes are pain, satisfaction of the patient and influence of Independent factors such as Age and Body mass index.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •abnormal pap smear
- •first colposcopy ever
排除标准
- •pregnancy
- •bleeding disorder
- •the use of blood thinner
- •language barrier
- •unwillingness to participate
结局指标
主要结局
Blood loss after 15 minutes (5-step visual analogue scale)
时间窗: 15 minutes
blood loss 15 minutes after biopsy will be measured judging the amount of blood on the sanitary napkin (5-step visual analogue scale)
次要结局
- Blood loss after 6 hours (5-step visual analogue scale)(6 hours)
- Blood loss after 24 hours (5-step visual analogue scale)(24 hours)
- Sensation of pain after 15 minutes (10-step visual analogue scale)(15 minutes)
- Overall Sensation of pain after 24 hours (10-step visual analogue scale)(24 hours)
- Blood loss after 3 hours (5-step visual analogue scale)(3 hours)
- Overall Satisfaction of the Patient after 24 hours (10-step visual analogue scale)(24 hours)
研究者
Dr. med. Ziad Hilal
Dr. med. Ziad Hilal
Zydolab - Institute of Cytology and Immune Cytochemistry
研究点 (4)
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