Randomized Controlled Study of Different Pain Scores in Single-Port Access (SPA) Laparoscopic Hysterectomy Versus Conventional Laparoscopic Hysterectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain score measured by visual analog scale
研究概览
简要总结
Purpose:
The attempt to further reduce the operative trauma in laparoscopic hysterectomy led in new technique such as Single-Port Access (SPA) laparoscopic surgery. This new technique is considered as painless procedure and better cosmetic effect but there are not any publications to study a possible different pain score and cosmetic effect in new techniques versus conventional laparoscopic hysterectomy. In this randomized controlled study the researchers have investigated the pain scores and cosmetic satisfaction by modified body image scale and cosmetic scar scale.
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
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 30-60, female
- •Symptomatic (Dysmenorrhea, Palpable mass, Pelvic pain or discomfort, Urinary symptom, Increasing size, Menorrhagia) myomas or adenomyosis
- •Suspected uterine myoma and/or adenomyosis on transvaginal ultrasonography (USG)
- •At least a 6-month thorough follow-up record available
- •Informed consent
排除标准
- •Endometrial hyperplasia without myoma or adenomyosis
- •Body Mass Index more than 30
- •Huge uterus defined by longitudinal uterine diameter larger than 10cm and anteroposterior diameter larger than 8cm in USG
研究组 & 干预措施
conventional laparoscopic hysterectomy
Three or four ports conventional laparoscopic hysterectomy
干预措施: conventional laparoscopic hysterectomy (Procedure)
SPA laparoscopic hysterectomy
Single umbilical incision laparoscopic hysterectomy
干预措施: SPA laparoscopic hysterectomy (Procedure)
结局指标
主要结局
Pain score measured by visual analog scale
时间窗: postoperative 24 hours
次要结局
- Modified body image scale and cosmetic scar scale(postoperative 6 months)