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临床试验/NCT02823119
NCT02823119Unknown2 期

Mini-hysteroscopy Versus Conventional Office Hysteroscopy in Nulliparous Patients Undergoing Diagnostic Office Hysteroscopy: A Randomized Controlled Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年8月最近更新:
适应症

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

入选标准

  • Nulliparous patients

排除标准

  • Parous patients, menopausal status, cervical pathology, and previous cervical surgery

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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Usama M Fouda

M.D, PhD

Cairo University

研究点 (1)

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