Benign Hysterectomy; a Randomized Controlled Trial Comparing Robotic Hysterectomy With Vaginal Hysterectomy and Traditional Laparoscopic Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Cost of surgery
研究概览
简要总结
A randomised controlled trial comparing hysterectomy by minimally invasive surgical methods; robotic hysterectomy versus vaginal hysterectomy or traditional laparoscopic hysterectomy; outcome and cost analyses.
详细描述
Laparoscopic surgery is advantageous compared to open surgery in terms of patient morbidity, shorter hospitalization and a more rapid return to daily activities. Robot-assisted laparoscopic surgery have facilitated a higher proportion of minimally invasive surgery first and foremost within gynecologic oncology.It is not clear whether or not this is true for less advanced surgery where a vaginal approach or a traditional laparoscopic approach is possible.
Robot-assisted surgery is associated with additional cost due to investment and more expensive surgical equipment. The study is performed to investigate whether or not performing hysterectomy for benign conditions with robotic surgery will be advantageous in terms of shorter operating time, less complications, less conversions to open surgery, and shorter hospital stay in comparison to other minimally invasive procedures such as vaginal hysterectomy and traditional laparoscopic hysterectomy.
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •indication for hysterectomy for benign disease or prophylactic surgery due to hereditary cancer
- •size of uterus and vagina allows for retrieval by the vaginal route
- •maximum uterine size equivalent to 16 weeks of pregnancy
- •informed consent
排除标准
- •malignant disease
- •known extensive intra-abdominal adhesions
- •anaesthesiological contraindications to laparoscopic surgery
- •women with pacemaker or other implants where electrosurgery is to be avoided
- •immunoincompetent women
- •simultaneous need for prolapse surgery
- •women with known defects of the hemostasis
- •allergies towards metronidazole and doxycycline
- •inability to understand patient information
研究组 & 干预措施
Robotic hysterectomy
Minimally invasive hysterectomy by robotic surgery
干预措施: Vaginal or laparoscopic hysterectomy (Procedure)
Vaginal or laparoscopic hysterectomy
Minimal invasive hysterectomy by vaginal or traditional laparoscopic surgery.
干预措施: Robotic hysterectomy (Device)
结局指标
主要结局
Cost of surgery
时间窗: 4 months
The cost of surgery includes the actual surgery (anaesthesia, OR-nurse, circulating nurse, doctors and use of the OR) as well as the length of the inpatient stay. The cost for conversions to open surgery, reoperations, readmissions, and any additional cost associated with additional procedures or medical interventions such as radiological examinations and blood transfusions. Based on the estimated cost of surgical material, use of the operating room and cost of anaesthesia each benign hysterectomy performed with robotic surgery would need to be 50 minutes shorter than other minimal invasive procedures to compensate for the additional cost.
次要结局
- Patient outcome(4 months)