Feasibility, Effectiveness and Safety of 3000 Hysteroscopies in Outpatient Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Feasibility: proportion of hysteroscopies that could be satisfactorily performed
研究概览
简要总结
Study Objective: The main objective of the study is to assess the feasibility, effectiveness and safety of outpatient hysteroscopies performed in our Office Hysteroscopy Unit.
Design: Retrospective observational study of prospectively collected data from the Office Hysteroscopy Unit database.
Setting: Tertiary care university hospital
Patients: Three thousand patients who consecutively attended an ambulatory hysteroscopy in our centre from may 2008 to october 2019
Interventions: The Office hysteroscopy was performed with several rigid 5-6 mm diameter devices when indicated with a diagnostic and/or therapeutic purpose
详细描述
Retrospective observational study of our prospectively collected database of 3000 consecutive hysteroscopies performed from may 2008 to october 2019 in our Office Hysteroscopy Unit (OHU).
All the patients who attended an ambulatory hysteroscopy in our centre during the study period were included. There were not any exclusion criteria and all data were prospectively collected in a computer database.
The primary endpoint was to determine the main results of the Outpatient Hysteroscopy Unit in terms of feasibility, effectiveness and safety. Feasibility was defined as the proportion of explorations that could be satisfactorily performed. Effectiveness was evaluated through the percentage of cases that were solved in our outpatient setting and did not require the operating room to complete their diagnosis or treatment. Safety was assessed as the percentage of complications registered.
In addition, we registered the intensity of the pain perceived by the patient with a Verbal Numerical Rating Scale (VNRS) (from 0 to 10) during the procedure and ten minutes later.
All the hysteroscopies were performed in our Office Hysteroscopy Unit by three experienced gynaecologists who performed the hysteroscopy assisted by a nurse.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All the patients who attended an ambulatory hysteroscopy in our centre.
排除标准
- •There were not any exclusion criteria.
结局指标
主要结局
Feasibility: proportion of hysteroscopies that could be satisfactorily performed
时间窗: 3 months
Feasibility refers to the proportion of hysteroscopies that could be satisfactorily performed
Efectiveness: Percentage of cases that were solved in our outpatient setting and did not require the operating room to complete their diagnosis or treatment
时间窗: 3 months
Percentage of cases that were solved in our outpatient setting and did not require the operating room to complete their diagnosis or treatment
Safety: Percentage of complications registered
时间窗: 3 months
Percentage of complications registered.
次要结局
- Pain during the hysteroscopy and 10 minutes later: Verbal Numerical Rating Scale (VNRS)(3 months)