VITOM Study: A Randomized, Controlled Trial.

Sponsor

University of Louisville (Other)

Overall Status

Completed

CT.gov ID

NCT03120689

Collaborator

KARL STORZ Endoscopy-America, Inc. (Industry)

145

Enrollment

Location

Arms

Actual Duration (Months)

4.8

Patients Per Site Per Month

Study Details

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	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	N/A

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

Actual Enrollment :

145 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 :

Jun 1, 2016

Actual Primary Completion Date :

Mar 1, 2018

Actual Study Completion Date :

Dec 1, 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

Learner satisfaction [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.