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

University of North Carolina (UNC)

Status: Completed

Conditions: Pelvic Organ Prolapse

Treatments: Procedure: Colpassist vaginal positioning device; Procedure: Traditional vaginal positioning device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02367235

14-1834

Details and patient eligibility

About

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

Full 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.

Enrollment: 52 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups

Traditional vaginal positioning device

Experimental group

Description:

Patients will undergo their robotic-assisted sacrocolpopexy using a vaginally placed endo anal sizer.

Treatment:

Procedure: Traditional vaginal positioning device

Colpassist vaginal positioning device

Experimental group

Description:

Patients will undergo their robotic-assisted sacrocolpopexy using a vaginally placed Colpassist vaginal manipulator.

Treatment:

Procedure: Colpassist vaginal positioning device