Bipolar 15 Charrières (Ch.) Office Resectoscope : Polypectomy Without Anesthesia - Prospective Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Hopital Foch
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Feasibility of polypectomy, with a mini-resectoscope of 15 bipolar careers, without general anesthesia or analgo-sedation
研究概览
简要总结
This study aimed to the feasibility of polypectomy without anesthesia using a 15 Ch. resectoscope in women with uterine polyps.
详细描述
Endometrial polyps are frequent gynecological pathologies leading to metrorrhagia, infertility, miscarriages and the risk of transformation into malignant pathology. The discovery of an endometrial polyp requires its removal.
The treatment of endometrial polyps is conventionally carried out by hysteroscopic resection under general anesthesia with a bipolar resector of 22 Charrières (Ch) or more after dilation of the uterine cervix in the operating room.
Following the recent appearance of a 15 Ch. bipolar mini-resectoscope, it seems that uterine dilation and anesthesia could be avoided by reducing the caliber of the instrument.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Female patients aged 18 or over
- •Patients with 1 to 2 endometrial polyps
- •Polyps diagnosed by ultrasound and / or diagnostic hysteroscopy following a check-up for menometrorrhagia, infertility or during a check-up
- •Polyps measuring less than 3 cm
- •Have signed a consent form
- •Be affiliated with a Health Insurance plan.
排除标准
- •Pregnant or lactating patient
- •Cervical stenosis
- •Patient having more than 2 polyps
- •Polyps measuring 3 cm or more
- •Malignant cells on histology
- •Associated indication of endometrectomy or other endo-uterine gesture
- •Hypersensitivity to remifentanil or to other fentanyl derivatives or to any of the excipients of the specialty used
- •Hypersensitivity to propofol or to any of the excipients of the specialty used
- •Cardiac pathology
- •Diaphragmatic hernia
- •Morbid obesity (BMI> 35)
- •Invasive cervical cancer
- •Chronic obstructive pulmonary disease
- •Patient presenting a strictly greater than 4 on a pain scale (from 0 to 10) during a diagnostic hysteroscopy
- •Does not speak and / or understand French
- •Be deprived of liberty or under guardianship.
结局指标
主要结局
Feasibility of polypectomy, with a mini-resectoscope of 15 bipolar careers, without general anesthesia or analgo-sedation
时间窗: 1 day (surgery)
Use or not of general anesthesia or analgo-sedation during the surgery
次要结局
- Patient satisfaction(4 months)
- Pain assessment during and after surgery(1 day (surgery))
- Identification of factors influencing the success of the main criterion(4 months)
- Capacity and clinical condition of the patient allowing her discharge(1 day (surgery))
- Post operative diagnostic hysteroscopy result(4 months)