Clinical trial NCT02367235: Analysis of Procedural Times Using Colpassist for Robotic-Assisted Sacrocolpopexy; a Randomized Controlled Trial
Official title: Analysis of Robotic Procedural Times Using the Colpassist Vaginal Positioning Device for Robotic-Assisted Sacrocolpopexy; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: robotic
sacrocolpopexy
Colpassist
vaginal positioning device
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
name: Intuitive Surgical
First posted: 2015-02-20
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Comparison of duration of surgical steps during sacral colpopexy
timeFrame: Intraoperative
Secondary outcomes:
measure: Surgeon and surgical-assistant satisfaction with the device
timeFrame: On the day of surgery
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill - Female Pelvic Medicine and Reconstructive Surgery
state: North Carolina
Study officials:
affiliation: UNC-Chapel Hill
name: Elizabeth Geller, MD
role: PRINCIPAL_INVESTIGATOR
References: