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Completed

NCT Number: NCT02367235

Analysis of Procedural Times Using Colpassist 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.

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Key information

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina, Chapel Hill - Female Pelvic Medicine and Reconstructive Surgery

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Traditional vaginal positioning device

Procedure

A vaginally placed endo-anal sizer will be used to position the vagina during surgery.

Colpassist vaginal positioning device

Procedure

A vaginally placed Colpassist will be used to position the vagina during surgery.

Primary outcomes

  1. Comparison of duration of surgical steps during sacral colpopexy

    Time frame: 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 outcomes

  1. Surgeon and surgical-assistant satisfaction with the device

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Boston Scientific Corporation
  • Intuitive Surgical

Registry information

Official study title

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

Acronym: ACRAS

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 20, 2015
Registry last updated
Apr 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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