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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-04-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Traditional vaginal positioning device

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

Group Type EXPERIMENTAL

Traditional vaginal positioning device

Intervention Type PROCEDURE

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

Colpassist vaginal positioning device

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

Group Type EXPERIMENTAL

Colpassist vaginal positioning device

Intervention Type PROCEDURE

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

Interventions

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Traditional vaginal positioning device

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

Intervention Type PROCEDURE

Colpassist vaginal positioning device

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age greater than or equal to 18 years old
* Planned robotic-assisted sacrocolpopexy
* English speaking
* Prior hysterectomy (either total or supra-cervical)