Prospective Randomized Controlled Trial to Analyze the Benefits of Single Port Laparoscopic Myomectomy in the View of Cosmetics and Patient Satisfaction
试验速览
- 阶段
- 不适用
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Cosmetic benefits of single port laparoscopic myomectomy to conventional myomectomy in the view of scar evaluation
研究概览
简要总结
This study is about the evaluation of which benefits single port laparoscopic myomectomy has in the perspective of cosmetics and patient satisfaction.
详细描述
There were several studies about feasibility and cosmetic benefit of single port laparoscopic adnexal surgery and hysterectomy compared to conventional multiport laparoscopic surgery. Meanwhile, no study mentioned benefit of single port laparoscopic surgery in myomectomy because single port myomectomy needs more labor and operator's skill than other pelvic surgery. At this point, the investigators need to verify the effectiveness and benefit of single port laparoscopic myomectomy.
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
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •premenopausal women
- •image confirmed myoma
- •scheduled to have laparoscopic myomectomy
- •number of myoma =<4 and largest size <10cm
排除标准
- •scheduled to have co-operation of other surgery
- •clinically significant hematologic abnormality
- •DM or malnutrition
- •under the medication which can affect wound healing
- •previous history of other pelvic surgery
结局指标
主要结局
Cosmetic benefits of single port laparoscopic myomectomy to conventional myomectomy in the view of scar evaluation
时间窗: for 8 weeks
The characteristics of scar such as color, pliability, and stiffness are willing to be measured in 1 week and 8 week later after myomectomy. The level of satisfaction of patients will also be evaluated.
Cosmetic benefits of single port laparoscopic myomectomy to conventional myomectomy in the view of patient satisfaction
时间窗: for 8 weeks
Patient satisfaction about scar formation after myomectomy are willing to be evaluated after surgery.
次要结局
- General composite characteristics of surgery procedure and outcome(1 week)
研究者
JungRyoel Lee
Assistant Professor
Seoul National University Hospital