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

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Completed
• CT.gov ID: NCT02367235
• Collaborator: Boston Scientific Corporation (Industry), Intuitive Surgical (Industry)
• Enrollment: 52
• Location: 1
• Arms: 2
• Duration (Months): 39
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Procedure: Traditional vaginal positioning device; Procedure: Colpassist vaginal positioning device	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Analysis of Robotic Procedural Times Using the Colpassist Vaginal Positioning Device for Robotic-Assisted Sacrocolpopexy; a Randomized Controlled Trial
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Apr 1, 2018
• Actual Study Completion Date: Apr 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Comparison of duration of surgical steps during sacral colpopexy [Intraoperative]

   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.

Secondary Outcome Measures

1. Surgeon and surgical-assistant satisfaction with the device [On the day of surgery]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of North Carolina, Chapel Hill - Female Pelvic Medicine and Reconstructive Surgery	Chapel Hill	North Carolina	United States	27599

Sponsors and Collaborators

• University of North Carolina, Chapel Hill
• Boston Scientific Corporation
• Intuitive Surgical

Investigators

• Principal Investigator: Elizabeth Geller, MD, UNC-Chapel Hill

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT02367235
• Other Study ID Numbers: 14-1834
• First Posted: Feb 20, 2015
• Last Update Posted: Apr 27, 2018
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by University of North Carolina, Chapel Hill: robotic; sacrocolpopexy; Colpassist; vaginal positioning device
• Additional relevant MeSH terms: Prolapse; Pelvic Organ Prolapse

Study Results

No Results Posted as of Apr 27, 2018