Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2026-01-05 @ 5:08 AM
Study NCT ID:
NCT02367235
Status:
COMPLETED
Last Update Posted:
2018-04-27
First Post:
2014-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Procedural Times Using Colpassist for Robotic-Assisted Sacrocolpopexy; a Randomized Controlled Trial
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
Analysis of Robotic Procedural Times Using the Colpassist Vaginal Positioning Device for Robotic-Assisted Sacrocolpopexy; a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACRAS
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: