Comparison Between Different Filling Pressures in Diagnostic Outpatient Hysteroscopy: A Double Blinded Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- adequate visualization of the uterine cavity
研究概览
简要总结
The aim of this study is to compare different filling pressures
详细描述
This study is a prospective double blinded randomised controlled trial. 240 women will be randomly divided into 3 groups, each containing 70 women. Randomisation will be performed using a computer generated random numbers and sealed envelopes.
Full history will be taken followed by general and local examination. The procedure will be done in the lithotomy position. Hysteroscopy will be done using a 5mm outer diameter continuous flow hysteroscope with a French working channel and a 30 degrees direction of view provided by Techno GmbH and CO. The hysteroscope will be introduced using the vaginoscopy technique, in which no speculum will be used. The cervix will be detected and the external os will be identified using the hysteroscope. The hysteroscope will be introduced in the uterine cavity. Saline will be used as the distension medium and the pressure will be set at 80mm Hg until the hysteroscope is introduced in the uterine cavity. After the hysteroscope is introduced into the uterine cavity, the filling pressure will remain at 80mm Hg in group1, will be reduced to 50mm Hg in group 2 and to 30mmHg in group 3. Randomisation will be double blind; neither the operator nor the patient will know the pressure during the procedure, a third party will set the pressure according to the computer generated random numbers.
The anterior wall, posterior wall and tubal ostea will be visualised, any polyps, adhesions septa, congenital malformations or submucous fibroids will be noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years
- •Has a clear Indication to have an outpatient hysteroscopy
- •Consent to participate in the study
排除标准
- •Premenstrual and midmenstrual patients.
- •Patients with missed periods.
- •Patients with known cardiac disease.
- •Patients who need operative hysteroscopy
研究组 & 干预措施
Filling pressure 80
After the hysteroscope is introduced into the uterine cavity, the filling pressure will remain at 80mm.
干预措施: Filling pressure 80 (Device)
Filling pressure 50.
After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 50mm Hg in this group
干预措施: Filling pressure 50 (Device)
illing pressure 30
After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 30mm Hg.
干预措施: Filling pressure 30 (Device)
结局指标
主要结局
adequate visualization of the uterine cavity
时间窗: 10 minutes after starting the procedure.
10 minutes after starting the procedure, the operator will document if adequate visualization was achieved using the allocated pressure. If visualization was not adequate, he will document that adequate visualization was not achieved using the allocated pressure and will ask for the pressure to be adjusted.
次要结局
- Pain perceived by the patient(10 minutes after starting the procedure)
- Pain perceived by the patient 30 minutes after starting the procedure.(30 minutes after starting the procedure.)