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

Primary Purpose

Pelvic Organ Prolapse, Prolapse of Vaginal Vault After Hysterectomy, Bulging of Vaginal Wall

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Live Surgery using VITOM
Live Surgery without VITOM
Video viewing with VITOM
Video viewing with standard handheld high-definition camera
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pelvic Organ Prolapse focused on measuring VITOM, Adult learners, Medical students, Residents, Vaginal surgery, Medical education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Health Care Outpatient Center and University of Louisville

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Live Surgery with VITOM

Live Surgery without VITOM

Video viewing with VITOM

Video viewing with standard camera

Arm 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.

Learner will assist in the traditional manner without the use of the VITOM camera followed by a short questionnaire.

Learner will watch a video taped using the VITOM camera followed by a short questionnaire.

Learner will watch a video taped using the standard hand-held high definition camera followed by a short questionnaire.

Outcomes

Primary Outcome Measures

Learner satisfaction
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.

Secondary Outcome Measures

Full Information

First Posted
June 22, 2016
Last Updated
April 17, 2019
Sponsor
University of Louisville
Collaborators
KARL STORZ Endoscopy-America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03120689
Brief Title
VITOM Study: A Randomized, Controlled Trial.
Acronym
VITOM
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
Collaborators
KARL STORZ Endoscopy-America, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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 .
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse, Prolapse of Vaginal Vault After Hysterectomy, Bulging of Vaginal Wall, Incontinence, Fistula
Keywords
VITOM, Adult learners, Medical students, Residents, Vaginal surgery, Medical education

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Live Surgery with VITOM
Arm Type
Active Comparator
Arm 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.
Arm Title
Live Surgery without VITOM
Arm Type
Active Comparator
Arm Description
Learner will assist in the traditional manner without the use of the VITOM camera followed by a short questionnaire.
Arm Title
Video viewing with VITOM
Arm Type
Active Comparator
Arm Description
Learner will watch a video taped using the VITOM camera followed by a short questionnaire.
Arm Title
Video viewing with standard camera
Arm Type
Active Comparator
Arm Description
Learner will watch a video taped using the standard hand-held high definition camera followed by a short questionnaire.
Intervention Type
Other
Intervention Name(s)
Live Surgery using VITOM
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Live Surgery without VITOM
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Video viewing with VITOM
Intervention Description
They will view the 10-minute standardized video filmed with the VITOM® camera.
Intervention Type
Other
Intervention Name(s)
Video viewing with standard handheld high-definition camera
Intervention Description
They will view the 10-minute standardized video filmed with the standard, handheld high-definition camera.
Primary Outcome Measure Information:
Title
Learner satisfaction
Description
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.
Time Frame
22 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Francis, M.D.
Organizational Affiliation
University of Louisville School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Care Outpatient Center and University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31169562
Citation
Hobson DTG, Meriwether KV, Gaskins JT, Uddin MN, Stewart JR, Gupta AS, Francis SL. Learner Satisfaction and Experience With a High-definition Telescopic Camera During Vaginal Procedures: A Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):105-111. doi: 10.1097/SPV.0000000000000748.
Results Reference
derived

Learn more about this trial

VITOM Study: A Randomized, Controlled Trial.

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