The Impact of Bladder Distention on Execution of Diagnostic Hysteroscopy Procedure; a Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Ease of Cervical Entry
研究概览
简要总结
The purpose of the study is to investigate the advantages and disadvantages of bladder filling during hysteroscopy procedure.
详细描述
Women who should have diagnostic hysteroscopy procedure will be randomly allocated into two groups. In the first group hysteroscopy will be performed with a filled bladder and in the second group procedure will be performed with an empty bladder. The women will be assigned into groups randomly. The duration of the procedure, feasibility of the procedure and tolerability of procedure will be recorded.
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 (Investigator)
入排标准
- 年龄范围
- 17 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who are at reproductive age
- •Women who are not pregnant at the time of presentation
- •Women who are not nulliparous
排除标准
- •Women who have previous cervical surgery or cervical incompetence.
- •Women who have genitourinary infection
- •Women who have profuse uterine bleeding or recent uterine perforation
- •Women who have neurological disorders affecting evaluation of pain.
研究组 & 干预措施
Empty Bladder
Hysteroscopy conducted under empty bladder.
干预措施: Hysteroscopy (Procedure)
Full Bladder
Hysteroscopy conducted under full bladder.
干预措施: Hysteroscopy (Procedure)
结局指标
主要结局
Ease of Cervical Entry
时间窗: 2 months
Ease of cervical entry which will be assessed by Likert scale.The outcome measures in this study were the ease of cervical entry (judged by the individual surgeons using a 5-point Likert scale: very difficult= 1, difficult= 2, fair = 3, easy= 4, and very easy = 5.
Pain Scoring(VAS)
时间窗: 2 months
Pain scoring was made by 10 cm visual analog scale. pain score (recorded by the patient on a 10 -point visual analog scale (VAS) which means pain increases with increasing number
次要结局
- Patient Acceptability and Pain Scoring(two months)
- Procedure Duration(two months)
研究者
CEM CELIK
Assistant Professor
Namik Kemal University