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VITOM Study: A Randomized, Controlled Trial.

University of Louisville (UOFL) logo

University of Louisville (UOFL)

Status

Completed

Conditions

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

Treatments

Other: Live Surgery using VITOM
Other: Live Surgery without VITOM
Other: Video viewing with VITOM
Other: Video viewing with standard handheld high-definition camera

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03120689
16.0002

Details and patient eligibility

About

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 .

Full 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.

Enrollment

145 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

145 participants in 4 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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