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Trial record 12 of 3257 for:    Louisville

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):

Study Description
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 .

Condition or disease Intervention/treatment
Pelvic Organ Prolapse Prolapse of Vaginal Vault After Hysterectomy Bulging of Vaginal Wall Incontinence Fistula Other: Live Surgery using VITOM Other: Live Surgery without VITOM Other: Video viewing with VITOM Other: Video viewing with standard handheld high-definition camera

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Learner Satisfaction and Experience With Use of a Vaginal Field Telescopic, High-definition Telescopic Camera System During Vaginal Reconstructive Procedures: A Randomized, Controlled Trial.
Actual Study Start Date : June 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : June 2018
Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03120689


Contacts
Contact: Sean Francis, M.D. (502) 561-7260 slfran12@louisville.edu
Contact: Deslyn Hobson, M.D. (502) 561-7260 dthobs01@louisville.edu

Locations
United States, Kentucky
Health Care Outpatient Center and University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Sherree Goss, RN    502-588-4333    skgoss01@louisville.edu   
Sub-Investigator: Kate Meriwether, M.D.         
Principal Investigator: Sean Francis, M.D.         
Sub-Investigator: Deslyn Hobson, M.D.         
Sub-Investigator: Casey Kinman, M.D.         
Sub-Investigator: James Stewart, D.O.         
Sponsors and Collaborators
University of Louisville
KARL STORZ Endoscopy-America, Inc.
Investigators
Principal Investigator: Sean Francis, M.D. University of Louisville School of Medicine
More Information

Responsible Party: Sean Francis, Chairman of Department of Obstetrics, Gynecology & Women's Health, University of Louisville
ClinicalTrials.gov Identifier: NCT03120689     History of Changes
Other Study ID Numbers: 16.0002
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sean Francis, University of Louisville:
VITOM
Adult learners
Medical students
Residents
Vaginal surgery
Medical education

Additional relevant MeSH terms:
Fistula
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical