The Use of a Morcellator in Operative Hysteroscopy for Benign Intracavitary Lesions: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 3
- 主要终点
- Completeness of resection of intracavitary lesions in 50 patients, when using a hysteroscopic Bigatti Shaver.
研究概览
简要总结
Polyps, intracavitary myomas and retained products of conception (RPOC) are common benign intracavitary lesions of the uterus and frequently cause abnormal uterine bleeding or pain. In general, intracavitary lesions are treated by operative hysteroscopy with bipolar resectoscopic removal under general anaesthesia, performed in the theatre (OR). Potential problems with this approach are thermal damage and impairment of visibility due to loose tissue fragments necessitating multiple entries for tissue removal.
Recently, lesion morcellation by hysteroscopy has been introduced as an alternative technique. Compared to the resectoscopic approach, morcellation is reportedly associated with a shorter total procedure time, smaller fluid deficit and number of insertions. A few trials also registered a higher success rate in completeness of resection.
No significant differences in odds of surgical complications have been reported.
Most hysteroscopic morcellators have diameters up to 8 mm, for which cervical dilation under general anaesthesia is usually needed.
Recently, companies have developed hysteroscopic morcellators with smaller diameters, e.g. 6.3 mm for the 19 Fr. intrauterine BIGATTI Shaver (IBS®). This means less need for cervical dilation, and potential use without anesthesia.
At this moment, there are no prospective studies available on feasibility of the 19 Fr. intrauterine BIGATTI Shaver (IBS®). Before implementing hysteroscopic morcellation in our department, we need a feasibility study assessing the method in standard conditions in the operation room or in ambulatory setting under sedation.
Trial objectives:
Assessment of the feasibility of hysteroscopic morcellation of benign uterine intracavitary lesions. The primary objective is to assess the completeness of hysteroscopic resection in patients undergoing the procedure under general anesthesia or sedation.
Secondary objectives are to assess perioperative parameters as operation time, need for cervical dilation, adverse events, pain, operator satisfaction; to assess quality of tissue for histological examination; to assess postoperative complications and pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patients:
- •Ultrasonographic diagnosis of an intracavitary lesion, according the IETA terms and definitions
- •endometrial polyp
- •FIGO 0-1 myoma (maximum diameter 2 cm)
- •RPOC (maximum diameter 2 cm, no enhanced myometrial vascularity)
排除标准
- •• Active vaginal bleeding
- •(possible) malignancy
- •Patient refusal
- •Pregnancy
- •Impossibility to access the uterine cavity (e.g. severe cervical stenosis)
- •Absence of intracavitary lesion (endometrial polyp, FIGO 0-1 myoma or RPOC) at hysteroscopy
结局指标
主要结局
Completeness of resection of intracavitary lesions in 50 patients, when using a hysteroscopic Bigatti Shaver.
时间窗: During surgery
If all tissue could be removed by the 19 Fr. intrauterine BIGATTI Shaver by direct visualisation at the end of the hysteroscopic procedure and at post-operative ultrasound evaluation.
次要结局
- Operation time(During surgery)
- Operator satisfaction, assessed by verbal rating scale(At the end of the procedure)
- Need for cervical dilation during procedure(During surgery)
- Volume of distension fluid used / loss (deficit) during procedure(During surgery)
- Complications(6 weeks after surgery)
- Pain on the first postoperative day, assessed by verbal rating scale(Day 1 post-operatively)
- Histology of the intracavitary lesion(6 weeks post-operatively)