NCT01483417Unknown3 期
Multi-institution, Randomized Trial for Efficacy and Safety of Single Incision Laparoscopic Surgery (SILS) Versus Conventional Laparoscopic Hysterectomy for the Treatment of Uterine Myoma or Adenomyosis
适应症
干预措施
试验速览
- 阶段
- 3 期
- 入组人数
- 240
- 试验地点
- 8
- 主要终点
- Conversion rate
研究概览
简要总结
Multi-center prospective randomized trial of single port laparoscopic surgery (SILS) versus conventional 3-4 ports laparoscopic hysterectomy. Hypothesis is that conversion rate of SILS is not inferior to that of conventional approach.
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
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Symptomatic (dysmenorrhea, palpable mass, pelvic pain or discomfort urinary symptom, increasing size, menorrhagia) myomas or adenomyomas
- •Uterine size < gestational age of 14 weeks
- •Informed consent
排除标准
- •Medical diseases such as heart failure, renal insufficiency, liver cirrhosis, pancreatitis, uncontrolled DM
- •Huge uterine size > gestational age of 14 weeks
研究组 & 干预措施
SILS
Experimental
Laparoscopic hysterectomy including LAVH, LH(a), and TLH using SILS port
干预措施: Single incision Laparoscopic hysterectomy (Procedure)
Conventional multi-port laparoscopic hysterectomy
Active Comparator
3-4 ports laparoscopic hysterectomy including LAVH, LH(a), or TLH
干预措施: Conventional laparoscopic hysterectomy (Procedure)
结局指标
主要结局
Conversion rate
时间窗: 1 week
Conversion means that events required additional port(s) or open laparotomy
次要结局
- Patient and Observer Scar Assessment Scale (POSAS)(12 weeks)
- Postoperative pain(postop. 1 day, 1 week)
研究者
Tae-Joong Kim
Clinical Assistant Professor
Samsung Medical Center
研究点 (8)
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