Predictive Factors for Successful Operative Hysteroscopy Using Tissue Removal Device (TruClear System) Without Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Procedure completed successfully
研究概览
简要总结
Background: Small-diameter operative hysteroscopes may allow to perform operative hysteroscopy without general anesthesia in selected patients. One of these instruments is the tissue removal device (TRD), which resects and removes intrauterine pathology such as endometrial polyps and retained products of conception (RPOC) with a diameter of ¬6 mm.
Objective: To assess the success rate and intraoperative pain of patients undergoing operative hysteroscopy without anesthesia with the TRD (TruClear Elite Mini-Hysteroscope) for removal of endometrial polyps or RPOC.
Methods: Prospective observational study. Participation in the study was offered to patients diagnosed with uterine polyps or RPOC on office diagnostic hysteroscopy. The patients filled out a digital questionnaire before and after the operation. A successful procedure was defined as complete hysteroscopic removal of the uterine pathology using the TruClear system. Oral 400 mcg misoprostol 12 hours before the procedure was prescribed for cervical ripening.
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
- •Diagnosis of polyp or retained products of conception in diagnostic hysteroscopy.
- •Medical need to remove the finding according to accepted criteria.
- •Patient's consent to the removal of the finding in a procedure without anesthesia.
- •Patient's consent to participate in the study.
排除标准
- •Any indication for performing the procedure under anesthesia in an operating room, such as:
- •Medical background requiring operation in an operating room.
- •Personal / mental background requiring procedure under general anesthesia.
- •Cervical stenosis
- •Previous failure to remove the finding in a procedure without anesthesia
- •Lack of response to performing the operation without anesthesia
- •The lack of response to participate in the study
- •A known diagnosis of malignancy from a previous sample of the polyp or endometrium
结局指标
主要结局
Procedure completed successfully
时间窗: Immediately after procedure
Was the procedure completed - yes/no
次要结局
- Prevalence of VAS (pain scale) > 5, five minutes after procedure(5 minutes after procedure)
- Acceptable procedure by the patient(5 minutes after procedure)
- Recommended procedure by the patient(5 minutes after procedure)
- Prevalence of VAS (pain scale) > 5 during procedure(Immediately after procedure)
研究者
Maayan Gal
investigator
Assaf-Harofeh Medical Center