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

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

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

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: Traditional vaginal positioning device; Procedure: Colpassist vaginal positioning device

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina, Chapel Hill - Female Pelvic Medicine and Reconstructive Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Traditional vaginal positioning device; Patients will undergo their robotic-assisted sacrocolpopexy using a vaginally placed endo anal sizer.	Procedure: Traditional vaginal positioning device; A vaginally placed endo-anal sizer will be used to position the vagina during surgery.
Experimental: Colpassist vaginal positioning device; Patients will undergo their robotic-assisted sacrocolpopexy using a vaginally placed Colpassist vaginal manipulator.	Procedure: Colpassist vaginal positioning device; A vaginally placed Colpassist will be used to position the vagina during surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Boston Scientific Corporation; Intuitive Surgical
• Investigators: Principal Investigator: Elizabeth Geller, MD, UNC-Chapel Hill

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: December 9, 2014
• First Submitted That Met QC Criteria: February 12, 2015
• First Posted (Estimate): February 20, 2015

Study Record Updates

• Last Update Posted (Actual): April 27, 2018
• Last Update Submitted That Met QC Criteria: April 25, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: robotic; sacrocolpopexy; Colpassist; vaginal positioning device
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 14-1834

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO