Pain Perception During Vaginoscopy Compared to Traditional Hysteroscopy for Hysteroscopy Morcellation in Outpatient Clinic: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Difference in pain perception between vaginoscopy group and traditional hysteroscopy group
研究概览
简要总结
This study is a randomized controlled trial take place in a fertility outpatient clinic in an academic hospital. Women between 18 and 52 years old requiring polypectomy or myomectomy by hysteroscopy morcellation for abnormal uterine bleeding or for fertility issue are included. The aim is to evaluate pain perception between vaginal and traditional hysteroscopy for hysteroscopic morcellation. The investigator's hypothesis is that pain perception is lower using vaginoscopy compared to traditional hysteroscopy.
详细描述
78 participants will be randomised in two groups:
- traditional hysteroscopy: under intravenous sedation, hysteroscopic morcellation is perform after speculum insertion, vaginal cleansing, and paracervical anesthesia with xylocain 1%.
- Vaginal hysteroscopy: under intravenous sedation, hysteroscopic morcellation is perform after vaginal cleansing using vaginal distension with saline solution
In addition to pain perception, other outcomes includes: complication rates, time to continue fertility treatment, time to pregnancy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 52 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •polyp or fibroid previously diagnosed by hysteroscopy
- •polyp less than 2 cm
- •submucosal fibroid (type 0 or 1 according to the 2011 FIGO uterine fibroid classification) less than 2 cm
- •if more than 1 fibroid: total fibroid have to be less or equal 4 cm
排除标准
- •cervical stenosis
- •polyp or fibroid more than 2 cm
- •pregnancy
- •blood dyscrasia
结局指标
主要结局
Difference in pain perception between vaginoscopy group and traditional hysteroscopy group
时间窗: immediately after intervention
10 point visual analog pain scale: 0 for no pain to 10 for unbearable pain
次要结局
- Difference in length of time of procedure between vaginoscopy group and traditional hysteroscopy group(immediately after intervention)
- Difference in proportion of uterine perforation between vaginoscopy group and traditional hysteroscopy group(immediatly after surgery)
- Difference in length of time to continue fertility treatment between vaginoscopy group and traditional hysteroscopy group(up to 1 year)
- Difference in proportion of vasovagal syncope between vaginoscopy group and traditional hysteroscopy group(immediately after surgery)
- Difference in length of time to pregnancy between vaginoscopy group and traditional hysteroscopy group(up to 1 year)