VITOM Study: A Randomized, Controlled Trial.



Status:Recruiting
Conditions:Hospital, Women's Studies
Therapuetic Areas:Other, Reproductive
Healthy:No
Age Range:18 - Any
Updated:9/26/2018
Start Date:June 2016
End Date:December 2018
Contact:Sean Francis, M.D.
Email:slfran12@louisville.edu
Phone:(502) 561-7260

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

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 .

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.

Inclusion Criteria:

- Adult learners (age >=18 years)

- Residents and medical students rotating in the field of gynecology at the University
of Louisville and within the group of learners who are available to observe and
participate in surgeries with the Urogynecologic team at any of the study sites.

Exclusion Criteria:

- Adult learners will be excluded if they have participated in the study prior, are
performing a role within the surgery that precludes their participating in one of the
study arms.

- If it is deemed by the surgical team that participation of the learner in the study or
filming of the surgery would compromise the quality of surgery or patient safety in
any manner.
We found this trial at
1
site
401 East Chestnut Street
Louisville, Kentucky 40202
Phone: 502-588-4333
?
mi
from
Louisville, KY
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