Chapel Hill, North Carolina 27599


Purpose:

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


Study summary:

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.


Criteria:

Inclusion Criteria: - Age greater than or equal to 18 years old - Planned robotic-assisted sacrocolpopexy - English speaking - Prior hysterectomy (either total or supra-cervical) Exclusion Criteria: - Age less than 18 years old - Non-English speaking - Pregnant women, or women desiring future pregnancy - Planned concomitant hysterectomy


NCT ID:

NCT02367235


Primary Contact:

Principal Investigator
Elizabeth Geller, MD
UNC-Chapel Hill

Taylor Brueseke, MD
Phone: 919-843-2574
Email: taylor.brueseke@unchealth.unc.edu


Backup Contact:

Email: egeller@med.unc.edu
Elizabeth Geller, MD
Phone: 919-966-4717


Location Contact:

Chapel Hill, North Carolina 27599
United States

Taylor J Brueseke, MD
Phone: 919-843-2574
Email: taylor.brueseke@unchealth.unc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

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