NCT03120689

VITOM Study: A Randomized, Controlled Trial.

Learner Satisfaction and Experience With Use of a Vaginal Field Telescopic, High-definition Telescopic Camera System During Vaginal Reconstructive Procedures: A Randomized, Controlled Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is research in which students are queried by questionnaires on their satisfaction with and experience with certain educational practices (use of a camera image projecting during a live surgery) or with pre-recorded video. As data collection only involves survey data collection and satisfaction with an educational experience, and randomization/intervention is only involving use of one type of educational method versus another .

Detailed description

As better training in vaginal surgery is a priority of gynecologic safety and quality organizations, optimizing learner satisfaction with vaginal surgery learning experiences is of paramount importance. Our purpose was to investigate if this unique camera system may have advantages in learner satisfaction both in the operating room and in video learning settings, therefore increasing the interest of the learner pool in vaginal surgery and optimizing their experience. This study has two main, non-dependent aims: Aim 1: The investigators aim to perform a randomized, controlled trial that compares a vaginally-mounted high-definition telescopic camera system (VITOM®) that can project live images in the operating room during vaginal surgery to traditional learner surgery observation practices, with the primary outcome of learner satisfaction as measured by validated adult learner satisfaction measures. Aim 2: The investigators aim to investigate in a randomized, controlled trial whether learners watching videos acquired with the VITOM® camera feel the video is more learner-friendly and optimal that videos acquired with traditional, tripod-mounted standard definition cameras.

Conditions

• Pelvic Organ Prolapse
• Prolapse of Vaginal Vault After Hysterectomy
• Bulging of Vaginal Wall
• Incontinence
• Fistula

Interventions

Type	Name	Description
OTHER	Live Surgery using VITOM	The vaginal operative field will be filmed with a VITOM® camera and the image from the VITOM® camera will be projected live within the operating room, so that the operating team can reference the image during the surgery.
OTHER	Live Surgery without VITOM	The vaginal operation will not be filmed and learner observation will take place in the traditional way, with them looking at the physical surgical field.
OTHER	Video viewing with VITOM	They will view the 10-minute standardized video filmed with the VITOM® camera.
OTHER	Video viewing with standard handheld high-definition camera	They will view the 10-minute standardized video filmed with the standard, handheld high-definition camera.

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-03-01
• Completion: 2018-12-01
• First posted: 2017-04-19
• Last updated: 2019-04-19

Locations

1 site across 1 country: United States