Operative Hysteroscopy for Fibroma by Classic Resection Versus Morcellation: a Ramdomised Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- duration of procedure
研究概览
简要总结
Hysteroscopic surgery is the gold standard for intra uterine pathology especially fibroma. Limit of this technic is duration of procedure which is correlated to operative complications. So, for patient with large fibrome or several fibromas, this technic is not indicated or performs in several times. A new technic of hysteroscopic surgery is available which is quicker than conventional technic. This technic is poorly evaluated. Aim of this study is to evaluate both technics on procedure duration.
详细描述
Material and Methods
We propose a monocentric-randomised study. Inclusion criteria are women over 18 years requiring hysteroscopic surgery for fibroma. After informed consent, patients will be randomised in two groups: hysteroscopic surgery with morcellation technic and conventional hysteroscopy technic with resection. The main objective is duration of procedure. Secondary objectives are characteristics and perioperative complications (distension media quantity, cervical injury, uterine perforation), immediate et long term postoperative data's (postoperative pain and synechia). We hypothesis hysteroscopic with morcellation reduces duration of procedure of 50%. The estimated size of population number is 30 per group and 60 for the study.
Expected results
We expected a significant decrease of procedure duration with hysteroscopic morcellation. This data will be interesting according peroperative complications are correlated to procedure duration and allow hysteroscopic surgery to patients with large or several fibromas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patient who is at least 18 years.
- •Patient under effective contraception.
- •Patient who underwent ultrasound confirming the presence of at least one or both uterine fibroids with a diameter less than 6 cm for the largest fibroid.
- •Patient who underwent diagnostic hysteroscopy confirming the presence of one or two uterine fibroids classified as Type 0, 1 or 2 according to FIGO classification (10).
- •Patient with an indication of intrauterine fibroid resection (bleeding disorders fetilité) by hysteroscopy.
- •Patient who agreed to participate in the study and who signed informed consent.
排除标准
- •Early Removal linked to patient's wish
结局指标
主要结局
duration of procedure
时间窗: intraoperative
The duration of the operative hysteroscopy is the period between the first introduction and the last out of the hysteroscope.
次要结局
- Distension fluid amount used during hysteroscopy(intraoperative)
- Cervical tear(intraoperative)
- The stopping rate of operative hysteroscopy before complete resection:(intraoperative)
- Postoperative pain upon awakening on a visual scale 0-10(6 hours after end of procedure)
- The postoperative adhesions rate diagnosed by hysteroscopy control(1 month)