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

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ClinicalTrials.gov Identifier: NCT03120689
Recruitment Status : Recruiting
First Posted : April 19, 2017
Last Update Posted : April 19, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

June 22, 2016
April 19, 2017
April 19, 2017
June 2016
March 2018   (Final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
VITOM Study: A Randomized, Controlled Trial.
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 .

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Other
  • Pelvic Organ Prolapse
  • Prolapse of Vaginal Vault After Hysterectomy
  • Bulging of Vaginal Wall
  • Incontinence
  • Fistula
  • 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.
  • 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.
    Intervention: Other: Live Surgery using VITOM
  • 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.
    Intervention: Other: Live Surgery without VITOM
  • Active Comparator: Video viewing with VITOM
    Learner will watch a video taped using the VITOM camera followed by a short questionnaire.
    Intervention: Other: Video viewing with VITOM
  • 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.
    Intervention: Other: Video viewing with standard handheld high-definition camera
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
June 2018
March 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact: Sean Francis, M.D. (502) 561-7260 slfran12@louisville.edu
Contact: Deslyn Hobson, M.D. (502) 561-7260 dthobs01@louisville.edu
United States
 
 
NCT03120689
16.0002
No
Not Provided
Plan to Share IPD: No
Sean Francis, University of Louisville
University of Louisville
KARL STORZ Endoscopy-America, Inc.
Principal Investigator: Sean Francis, M.D. University of Louisville School of Medicine
University of Louisville
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP