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 : September 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Factorial Assignment|
|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|
|Actual Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||December 2018|
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.
- 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.
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
|Contact: Sean Francis, M.D.||(502) firstname.lastname@example.org|
|Contact: Deslyn Hobson, M.D.||(502) email@example.com|
|United States, Kentucky|
|Health Care Outpatient Center and University of Louisville||Recruiting|
|Louisville, Kentucky, United States, 40202|
|Contact: Sherree Goss, RN 502-588-4333 firstname.lastname@example.org|
|Sub-Investigator: Kate Meriwether, M.D.|
|Principal Investigator: Sean Francis, M.D.|
|Sub-Investigator: Deslyn Hobson, M.D.|
|Sub-Investigator: James Stewart, D.O.|
|Sub-Investigator: Ankita Gupta, M.D.|
|Principal Investigator:||Sean Francis, M.D.||University of Louisville School of Medicine|