Robotic Versus Laparoscopic Surgery for Severe Deep Endometriosis: a Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- NRS (Numeric rating scale) Score for pain
研究概览
简要总结
The objective of this study is to examine whether robot-assisted laparoscopy is superior compared to conventional laparoscopy as regards to patient outcome.
详细描述
The objective of this prospective, randomized trial is to examine whether robot-assisted laparoscopy is superior compared to conventional laparoscopy as regards to patient outcome at 6, 12 and 24 months postoperatively, measured by questionnaires concerning the pain symptoms and disease-related quality-of life.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA (American Society of Anesthesiologists physical status classification) 1-3
- •Diagnosed deep endometriosis (MRI)
- •Patient has symptoms
- •Operative treatment is indicated
- •Patient is able to give informed consent
排除标准
- •Recurring rectosigmoid endometriosis
结局指标
主要结局
NRS (Numeric rating scale) Score for pain
时间窗: Immediately postoperatively (24 hours) and 6, 12 and 24 months postoperatively
The surgical outcome as regards to pain symptoms (NRS questionnaire), absolute scores and change from baseline for both study groups.
次要结局
- Endometriosis-related quality-of-life(6, 12 and 24 months)
- Intraoperative measures(Up to 300 minutes (intraoperative))
- Sexual quality-of-life questionnaire(6, 12 and 24 months)
- General 15 dimensional health-related quality-of-life questionnaire(6, 12 and 24 months)
- Factors concerning ERAS (Enhanced recovery after surgery)(Up to 7 days (Hospital stay))
- Cost(Primary hospital stay and 24 months, for both study groups.)
- Complications(30 days)
研究者
Sari Koivurova
Assistant Chief of Gynecology
University of Oulu