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临床试验/NCT02367235
NCT02367235已完成不适用

Analysis of Robotic Procedural Times Using the Colpassist Vaginal Positioning Device for Robotic-Assisted Sacrocolpopexy; a Randomized Controlled Trial

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2015年1月最近更新:
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
52
试验地点
2
主要终点
Comparison of duration of surgical steps during sacral colpopexy

研究概览

简要总结

The purpose of this study is to evaluate the efficiency of the Colpassist vaginal positioning device during robotic-assisted sacrocolpopexy.

详细描述

The purpose of this research study is to evaluate the efficiency of the Colpassist (Boston Scientific, Natick, MA) vaginal positioning device used during robotic-assisted sacrocolpopexy. Traditionally, vaginal positioning during robotic-assisted sacrocolpopexy is done using a device that was not designed specifically for sacrocolpopexy, commonly a vaginally placed endo anal sizer. It is possible the Colpassist device will result in shorter operative times because Colpassist is flat which makes it easier to sew against. Also, the width of the device is designed to be similar to the width of the vagina which should improve visibility during surgery.

Enrolled patients will be randomized to undergo their planned robotic-assisted sacrocolpopexy using either a vaginally placed endo anal sizer or a vaginally placed Colpassist vaginal positioning device. Both surgeon and patient will be blinded to which device was used at the time of surgery. Length of time to complete each step of the sacral colpoexy that involves use of a vaginal positioning device (dissection of the anterior and posterior vaginal walls, attachment of anterior and posterior vaginal mesh, attachment of sacral mesh) will be recorded during the surgery to measure operative efficiency. Surgeon and surgical-assistant satisfaction will be recorded with each device.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age greater than or equal to 18 years old
  • Planned robotic-assisted sacrocolpopexy
  • English speaking
  • Prior hysterectomy (either total or supra-cervical)

排除标准

  • Age less than 18 years old
  • Non-English speaking
  • Pregnant women, or women desiring future pregnancy
  • Planned concomitant hysterectomy

研究组 & 干预措施

Traditional vaginal positioning device

Experimental

Patients will undergo their robotic-assisted sacrocolpopexy using a vaginally placed endo anal sizer.

干预措施: Traditional vaginal positioning device (Procedure)

Colpassist vaginal positioning device

Experimental

Patients will undergo their robotic-assisted sacrocolpopexy using a vaginally placed Colpassist vaginal manipulator.

干预措施: Colpassist vaginal positioning device (Procedure)

结局指标

主要结局

Comparison of duration of surgical steps during sacral colpopexy

时间窗: Intraoperative

Length of time will be recorded for each step of the sacral colpopexy that utilizes the vaginal positioning device (dissection of anterior vaginal wall, dissection of posterior vaginal wall, attachment of anterior vaginal mesh, attachment of posterior vaginal mesh, and attachment of sacral mesh) during the surgery. No follow up will be required by the patient.

次要结局

  • Surgeon and surgical-assistant satisfaction with the device(On the day of surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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