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VITOM Study: A Randomized, Controlled Trial.

NCT03120689 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2019-04-19

No results posted yet for this study

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 .

Conditions

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

Interventions

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.

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.

OTHER

Video viewing with VITOM

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

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.

Sponsors & Collaborators

  • KARL STORZ Endoscopy-America, Inc.

    collaborator INDUSTRY

  • University of Louisville

    lead OTHER

Principal Investigators

  • Sean Francis, M.D. · University of Louisville School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-03-31
Completion
2018-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03120689 on ClinicalTrials.gov