VITOM Study: A Randomized, Controlled Trial.

Not Applicable

Completed

• Conditions: Bulging of Vaginal Wall; Incontinence; Fistula; Pelvic Organ Prolapse; Prolapse of Vaginal Vault After Hysterectomy
• Interventions: Other: Live Surgery without VITOM; Other: Video viewing with standard handheld high-definition camera; Other: Live Surgery using VITOM; Other: Video viewing with VITOM

• Registration Number: NCT03120689
• Lead Sponsor: University of Louisville

Brief 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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2017-04-16
• Study First Posted: 2017-04-19
• Primary Completion: 2018-03
• Study Completion: 2018-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-17
• Last Update Posted: 2019-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Live Surgery without VITOM	Live Surgery without VITOM	Learner will assist in the traditional manner without the use of the VITOM camera followed by a short questionnaire.
Video viewing with standard camera	Video viewing with standard handheld high-definition camera	Learner will watch a video taped using the standard hand-held high definition camera followed by a short questionnaire.
Live Surgery with VITOM	Live Surgery using 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.
Video viewing with VITOM	Video viewing with VITOM	Learner will watch a video taped using the VITOM camera followed by a short questionnaire.

Primary Outcome Measures

Name	Time	Method
Learner satisfaction	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.

Trial Locations

Locations (1)

Health Care Outpatient Center and University of Louisville; 🇺🇸 Louisville, Kentucky, United States