VITOM Study: A Randomized, Controlled Trial. (VITOM)

April 17, 2019 updated by: Sean Francis, University of Louisville

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Health Care Outpatient Center and University of Louisville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Live Surgery with VITOM
Learner will not assist during the surgery, but watch the live surgery that is projected on a screen via the VITOM camera followed by a short questionnaire.
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.
Active Comparator: Live Surgery without VITOM
Learner will assist in the traditional manner without the use of the VITOM camera followed by a short questionnaire.
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.
Active Comparator: Video viewing with VITOM
Learner will watch a video taped using the VITOM camera followed by a short questionnaire.
Other: Video viewing with VITOM
They will view the 10-minute standardized video filmed with the VITOM® camera.
Active Comparator: Video viewing with standard camera
Learner will watch a video taped using the standard hand-held high definition camera followed by a short questionnaire.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
22 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

KARL STORZ Endoscopy-America, Inc.

Investigators

  • Principal Investigator: Sean Francis, M.D., University of Louisville School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

June 22, 2016

First Submitted That Met QC Criteria

April 16, 2017

First Posted (Actual)

April 19, 2017

Study Record Updates

Last Update Posted (Actual)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16.0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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