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| Name | Class |
|---|---|
| KARL STORZ Endoscopy-America, Inc. | INDUSTRY |
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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 .
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 (VITOMĀ®) 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 VITOMĀ® camera feel the video is more learner-friendly and optimal that videos acquired with traditional, tripod-mounted standard definition cameras.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Live Surgery with VITOM | Active Comparator | 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. |
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| Live Surgery without VITOM | Active Comparator | Learner will assist in the traditional manner without the use of the VITOM camera followed by a short questionnaire. |
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| Video viewing with VITOM | Active Comparator | Learner will watch a video taped using the VITOM camera followed by a short questionnaire. |
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| Video viewing with standard camera | Active Comparator | Learner will watch a video taped using the standard hand-held high definition camera followed by a short questionnaire. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live Surgery using VITOM | Other | The vaginal operative field will be filmed with a VITOMĀ® camera and the image from the VITOMĀ® camera will be projected live within the operating room, so that the operating team can reference the image during the surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Learner satisfaction | Comparing satisfaction scores using a visual analog scale of adult learners assigned to the (VITOMĀ®) camera group to the leaners who will be assigned to the No VITOM group during vaginal reconstructive surgery. | 22 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sean Francis, M.D. | University of Louisville School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Care Outpatient Center and University of Louisville | Louisville | Kentucky | 40202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31169562 | Derived | 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. |
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| Live Surgery without VITOM | Other | 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. |
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| Video viewing with VITOM | Other | They will view the 10-minute standardized video filmed with the VITOMĀ® camera. |
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| Video viewing with standard handheld high-definition camera | Other | They will view the 10-minute standardized video filmed with the standard, handheld high-definition camera. |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D005402 | Fistula |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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