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OpenTrials
Completed

NCT Number: NCT03120689

VITOM Study: 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 .

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Care Outpatient Center and University of Louisville

Louisville, Kentucky, 40202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Live Surgery using VITOM

Other

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.

Live Surgery without VITOM

Other

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.

Video viewing with VITOM

Other

They will view the 10-minute standardized video filmed with the VITOM® camera.

Video viewing with standard handheld high-definition camera

Other

They will view the 10-minute standardized video filmed with the standard, handheld high-definition camera.

Primary outcomes

  1. Learner satisfaction

    Time frame: 22 months

    Comparing satisfaction scores using a visual analog scale of adult learners assigned to the (VITOM®) camera group to the leaners who will be assigned to the No VITOM group during vaginal reconstructive surgery.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • KARL STORZ Endoscopy-America, Inc.

Registry information

Official study title

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

Acronym: VITOM

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 19, 2017
Registry last updated
Apr 19, 2019

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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