NCT05337605已完成不适用
Hand Driven Versus Motor Driven Hysteroscopic Tissue Removal System 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
- 87
- 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 (hand driven and motor driven morcellation). 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. Hysteroscopic morcellation is an effective, fast, and safe method for this. However, the differences between two different systems of hysteroscopic morcellation, motor-driven (Truclear incisor mini device) and hand-driven (Resectr 9fr) morcellation, are still unclear. The REMOvE9 study, in which women with a polyp were randomized between both techniques, is currently investigating the differences in short-term effectiveness between the two techniques.
- Research question/goal: To investigate the long-term results of the effectiveness of a hysteroscopic morcellation of intrauterine polyps. The two systems are compared with each other.
- Study design: This is a prospective cohort study. The patients previously participated in a randomized controlled trial (REMOvE9) 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 the REMOvE9 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: 1 to 4 years
Patient reported outcome by means of a questionnaire (yes/no, specify)
次要结局
- Rate of occurrence of new symptoms after initial intervention (abdominal pain, abnormal uterine blood loss, infections, other...) (+ cause, treatment)(1 to 4years)
- Chance of pregnancy after treatment(1 to 4 years)
- General satisfaction score in regard to initial treatment(1 to 4years)
- Recurrence interval (time to recurrence of endometrial polyp)(1 to 4years)
- Rate of recurrence of other symptoms (abdominal pain, infections, back pain, other..) (+ cause, treatment)(1 to 4 years)
- Satisfaction score in regard to symptoms (abdominal pain, abnormal uterine blood loss, other...)(1 to 4years)
- Rate of occurrence of new polyps (+ cause, treatment)(1 to 4years)
- Number of patients with symptom relief after initial intervention (abdominal pain, abnormal uterine blood loss, other...)(1 to 4years)
- Rate of need for additional treatment(1 to 4years)
研究者
研究点 (1)
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