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

Pelvic Organ Prolapse Clinical Trial

— ACRAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02367235
• Other study ID #: 14-1834
• Status: Completed
• Phase: N/A
• First received: December 9, 2014
• Last updated: April 25, 2018
• Start date: January 2015
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• Traditional vaginal positioning device
A vaginally placed endo-anal sizer will be used to position the vagina during surgery.
• Colpassist vaginal positioning device
A vaginally placed Colpassist will be used to position the vagina during surgery.

Locations

Country	Name	City	State
United States	University of North Carolina, Chapel Hill - Female Pelvic Medicine and Reconstructive Surgery	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Boston Scientific Corporation, Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of duration of surgical steps during sacral colpopexy	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.	Intraoperative
Secondary	Surgeon and surgical-assistant satisfaction with the device	Surgeon and surgical assistant satisfaction will be assessed via questionnaire immediately after surgery. No follow up will be required of the surgeons or the assistants.	On the day of surgery