VITOM Study: A Randomized, Controlled Trial.
VITOM
Learner Satisfaction and Experience With Use of a Vaginal Field Telescopic, High-definition Telescopic Camera System During Vaginal Reconstructive Procedures: A Randomized, Controlled Trial.
1 other identifier
interventional
145
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 22, 2016
CompletedFirst Posted
Study publicly available on registry
April 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedApril 19, 2019
April 1, 2019
1.7 years
June 22, 2016
April 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
22 months
Study Arms (4)
Live Surgery with VITOM
ACTIVE COMPARATORLearner 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.
Live Surgery without VITOM
ACTIVE COMPARATORLearner will assist in the traditional manner without the use of the VITOM camera followed by a short questionnaire.
Video viewing with VITOM
ACTIVE COMPARATORLearner will watch a video taped using the VITOM camera followed by a short questionnaire.
Video viewing with standard camera
ACTIVE COMPARATORLearner will watch a video taped using the standard hand-held high definition camera followed by a short questionnaire.
Interventions
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.
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.
They will view the 10-minute standardized video filmed with the VITOM® camera.
They will view the 10-minute standardized video filmed with the standard, handheld high-definition camera.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Louisvillelead
- KARL STORZ Endoscopy-America, Inc.collaborator
Study Sites (1)
Health Care Outpatient Center and University of Louisville
Louisville, Kentucky, 40202, United States
Related Publications (1)
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.
PMID: 31169562DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sean Francis, M.D.
University of Louisville School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chairman of Department of Obstetrics, Gynecology & Women's Health
Study Record Dates
First Submitted
June 22, 2016
First Posted
April 19, 2017
Study Start
June 1, 2016
Primary Completion
March 1, 2018
Study Completion
December 1, 2018
Last Updated
April 19, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share