Randomized Clinical Trial Comparing Conventional Laparoscopic and Robot-Assisted Laparoscopic Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Operative Time
研究概览
简要总结
Robotic-assisted surgery is becoming more prominent within the specialty of Gynecologic surgery with little direct evidence that it is if not better than traditional laparoscopic surgery, at least equivalent. We designed a randomized-controlled trial to compare operative times, length of hospital stay, estimated blood loss, and post-operative complications associated with these two methods of minimally invasive hysterectomy.
详细描述
The proposed study will be a non-blinded randomized control trial. Patients will be randomized into each group Conventional Laparoscopic Hysterectomy (Group #1) and Robot-Assisted Laparoscopic Hysterectomy (Group #2) using a random number generator. Data collection will occur during the following points of patient interaction: pre-operative appointment, the surgical procedure, the patient's hospitalization, first post-operative appointment, and final post-operative appointment.
The care for the patients enrolled in this study will not deviate from the standard care of patients who are currently undergoing laparoscopic and robot-assisted laparoscopic hysterectomy. The patients who present to the office for pre-operative history and physical examination for laparoscopic hysterectomy will be counseled about participation in this study. Basic data collection will commence at the pre-operative visiting, including: patient demographics, past medical history, past surgical history, physical exam findings, and imaging results. The pre-operative appointment will occur between one to thirty days prior to surgery. Intra-operative and immediate post-operative data will be collected by the surgical assistant (resident or fellow) and will include surgical procedure (conventional laparoscopic or robot-assisted), operative time, hematocrit, estimated blood loss, length of stay, and complications.
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 80 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Undergoing Hysterectomy
- •Able to consent to the procedure
排除标准
- •Medical conditions not allowing for pneumoperitoneum
- •Medical conditions not allowing proper ventilation during anesthesia
- •Pelvic organ prolapse amendable to a vaginal approach
- •Pregnant women
- •Patients undergoing planned combined procedures including bowel resection (other than coincidental appendectomy) or major urologic procedures.
研究组 & 干预措施
Laparoscopic Hysterectomy
Laparoscopic Hysterectomy
干预措施: Hysterectomy (Procedure)
Robot-assisted
Robot-assisted hysterectomy
干预措施: Hysterectomy (Procedure)
结局指标
主要结局
Operative Time
时间窗: Intra operative
The primary end point is difference in operative time
次要结局
- Complications(up to 6 weeks following intervention)
研究者
Timothy A Deimling
Fellow Minimally Invasive GYN Surgery
Milton S. Hershey Medical Center
