Laparoscopic Myomectomy Using Barbed or Conventional Sutures . A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Operative time
研究概览
简要总结
The aim of this study is to compare operative data and early postoperative outcomes of laparoscopic myomectomy using barbed sutures with those of laparoscopic myomectomy using conventional sutures .
详细描述
• Till now , there is only one small randomized controllrd study (n=22 in each arm) which compared the use of barbed suture with conventional suture in laparoscopic myomectomy .The myoma bed was closed with either conventional polyglactin suture or unidirectional barbed suture . The operative time was shorter in the barbed suture group (73.3 ± 21.4 min Vs. 80.7 ± 18.6 min) but this difference failed to reach statistical significance because of small sample size . However, the time required to suture the myoma beds was significantly lower in the barbed suture group .
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •the presence of one to three symptomatic intramural or subserosal myomas (with largest fibroid diameter less than 10 cm).
排除标准
- •submucosal myoma
- •calcified myomas
- •uterine size more than 16 weeks
- •suspension of genital malignancy
- •coagulation defects or concurrent anticoagulant therapy
- •pregnancy
- •compromised cardiopulmonary status
- •previous treatment with gonadotropin-releasing hormone analogue
- •contraindications for general anesthesia.
结局指标
主要结局
Operative time
时间窗: During myomectomy operation
次要结局
- Suturing time of myoma bed(During myomectomy operation)