NCT05337046已完成不适用
Hysteroscopic Tissue Removal System Versus Bipolar Resectoscopy for Polypectomy: Long-term Results
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Rate of recurrence of abnormal uterine blood loss (+ cause, treatment)
研究概览
简要总结
In this study, a comparison is made between two types of polyp resection methods (hysteroscopic tissue removal and bipolar resectoscopy). More specifically, the effects of the resection on symptoms such as abnormal uterine bleeding, and on the recurrence of polyps. The aim of the study is to find a superior method in terms of symptom relieve and polyp recurrence so this method can be used in gynaecological practice.
详细描述
- Rationale: Several techniques for hysteroscopic removal of intrauterine polyps exist today. Up until the first decade of this century, larger polyps were usually removed via bipolar resectoscopy. Later, the hysteroscopic tissue removal system (morcellation) was introduced in which the abnormal tissue is mechanically removed, which is then immediately aspirated. Previous studies comparing bipolar resection and morcellation show that this is an effective, fast, and safe method without major complications. However, the long-term results are still largely unknown.
- Research question/goal: To investigate the long-term results of the effectiveness of hysteroscopic removal of intrauterine polyps. Bipolar resection and morcellation are compared here.
- Study design: This is a prospective cohort study. The patients previously participated in a randomized study (2011-2014) and will now be contacted again for the completion of a one-time questionnaire. The study has an observational design.
- Study population: Women with a history of endometrial polyp that was previously removed via hysteroscopic morcellation in a previous study.
- Primary and secondary endpoints: The primary endpoint is the risk of recurrence of abnormal uterine bleeding at post-surgery follow-up. Secondary endpoints include recurrence of other symptoms, time to recurrence, symptom relief, onset of new symptoms, onset of new polyp, satisfaction with regards to symptoms, satisfaction with regards to the treatment in general, need for additional treatments for blood loss and occurrence of pregnancy (in subfertility group).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •participation in earlier study
排除标准
- 未提供
结局指标
主要结局
Rate of recurrence of abnormal uterine blood loss (+ cause, treatment)
时间窗: 8 to 10 years
Patient reported outcome by means of a questionnaire (yes/no, specify)
次要结局
- Recurrence interval (time to recurrence of endometrial polyp)(8 to 10 years)
- General satisfaction score in regard to initial treatment(8 to 10 years)
- Rate of need for additional treatment(8 to 10 years)
- Rate of recurrence of other symptoms (abdominal pain, infections, back pain, other..) (+ cause, treatment)(8 to 10 years)
- Chance of pregnancy after treatment(8 to 10 years)
- Rate of occurrence of new symptoms after initial intervention (abdominal pain, abnormal uterine blood loss, infections, other...) (+ cause, treatment)(8 to 10 years)
- Rate of occurrence of new polyps (+ cause, treatment)(8 to 10 years)
- Number of patients with symptom relief after initial intervention (abdominal pain, abnormal uterine blood loss, other...)(8 to 10 years)
- Satisfaction score in regard to symptoms (abdominal pain, abnormal uterine blood loss, other...)(8 to 10 years)
研究者
研究点 (1)
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