Phase 1 Study of Two Techniques in Hysteroscopy That Compare Carbon Dioxide Versus Saline Solution
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Evaluation of the comfort in office hysteroscopy
研究概览
简要总结
Nowadays,hysteroscopy is a golden standard procedure to describe the morphology of uterine cavity and investigate of abnormal uterine bleeding . The success of the procedure is based on the distension of the cavity . It can cause pain and discomfort and sometimes the procedure fails. . There are two techniques to make the procedure , one with gas and the other with saline solution. Objective: to compare two techniques concerning pain , procedure duration and image quality
详细描述
The objective of this study is to compare two techniques in office hysteroscopy.In this clinical trial postmenopausal women will undergo a diagnostic hysteroscopy using carbon dioxide or saline solution to uterine cavity distension.
There will be two groups of 70 women each. The objective is to determine which technique provides better image,time of procedure and less discomfort.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women post-menopausal with abnormal uterine bleeding, ultrasound with thick endometrial distorted
排除标准
- •Women with uterine malformations
- •Women with mental retardation
- •Women underwent pelvic radiotherapy
结局指标
主要结局
Evaluation of the comfort in office hysteroscopy
时间窗: one year
140 women will undergo office hysteroscopy to evaluate pain, time of the procedure and image quality using two techniques one with gas and the other with saline solution.
次要结局
未报告次要终点