Mini-hysteroscopy Versus Conventional Office Hysteroscopy in Nulliparous Patients Undergoing Diagnostic Office Hysteroscopy: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Intensity of pain
研究概览
简要总结
The aim of this study is to evaluate the effect of hysteroscope diameter on the pain experienced by nulliparous patients undergoing diagnostic office hysteroscopy.
详细描述
The results of the studies comparing the pain experienced by the patients undergoing conventional office hysteroscopy or mini-hysteroscopy were mixed. Several studies revealed that mini-hysteroscopy significantly reduced the procedure related pain and other studies revealed that the use of mini-hysteroscope was not associated with significant reduction in the procedure related pain. The aim of this study is to evaluate the effect of hysteroscope diameter on the pain experienced by nulliparous patients undergoing diagnostic office hysteroscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Nulliparous patients
排除标准
- •Parous patients, menopausal status, cervical pathology, and previous cervical surgery
研究组 & 干预措施
Mini-hysteroscopy
A rigid 2.7-mm hysteroscope with a 30° forward oblique lens and an outer sheath diameter of 3.3 mm.
干预措施: Mini-hysteroscopy (Device)
Conventional Office Hysteroscopy
A rigid 2.9-mm hysteroscope with a 30° forward oblique lens and an outer sheath diameter of 5 mm
干预措施: Conventional Office Hysteroscopy (Device)
结局指标
主要结局
Intensity of pain
时间窗: up to 30 minutes
Intensity of pain assessed by the Visual Analog Scale (VAS)"
次要结局
- Duration of procedure(intraoperative)