Pelvic Organ Prolapse Clinical Trial
Official title:
Analysis of Robotic Procedural Times Using the Colpassist Vaginal Positioning Device for Robotic-Assisted Sacrocolpopexy; a Randomized Controlled Trial
The purpose of this study is to evaluate the efficiency of the Colpassist vaginal positioning device during robotic-assisted sacrocolpopexy.
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.
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