NCT02367235

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
PROCEDURE	Traditional vaginal positioning device	A vaginally placed endo-anal sizer will be used to position the vagina during surgery.
PROCEDURE	Colpassist vaginal positioning device	A vaginally placed Colpassist will be used to position the vagina during surgery.

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2015-02-20
• Last updated: 2018-04-27

Locations

1 site across 1 country: United States