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临床试验/NCT02118974
NCT02118974已完成不适用

Randomized Clinical Trial Comparing Conventional Laparoscopic and Robot-Assisted Laparoscopic Hysterectomy

Milton S. Hershey Medical Center1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2014年5月1日最近更新:
适应症
干预措施

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

Experimental

Laparoscopic Hysterectomy

干预措施: Hysterectomy (Procedure)

Robot-assisted

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Timothy A Deimling

Fellow Minimally Invasive GYN Surgery

Milton S. Hershey Medical Center

研究点 (1)

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