Pelvic Organ ProlapseVITOMNCT03120689
VITOM Study: A Randomized, Controlled Trial.
A study testing Live Surgery using VITOM, Live Surgery without VITOM and Video viewing with VITOM in people with Pelvic Organ Prolapse and Prolapse of Vaginal Vault After Hysterectomy, run by University of Louisville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse, Prolapse of Vaginal Vault After Hysterectomy, Bulging of Vaginal Wall
- What is being tested?
- Live Surgery using VITOM, Live Surgery without VITOM and Video viewing with VITOM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Health Care Outpatient Center and University of Louisville
Louisville, Kentucky, 40202
About this study
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.
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 .
Read the 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.
- Conditions
- Pelvic Organ Prolapse, Prolapse of Vaginal Vault After Hysterectomy, Bulging of Vaginal Wall, Incontinence, Fistula
- Being tested
- Live Surgery using VITOM, Live Surgery without VITOM, Video viewing with VITOM, Video viewing with standard handheld high-definition camera
- Keywords
- VITOM, Adult learners, Medical students, Residents, Vaginal surgery, Medical education
- Medical subject headings
- Pelvic Organ Prolapse, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Surgery using VITOMOther
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.
Live Surgery without VITOMOther
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.
Video viewing with VITOMOther
They will view the 10-minute standardized video filmed with the VITOM® camera.
Video viewing with standard handheld high-definition cameraOther
They will view the 10-minute standardized video filmed with the standard, handheld high-definition camera.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Live Surgery using VITOM |
| 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. Receives: Other: Live Surgery without VITOM |
| Video viewing with VITOM | Active comparator | Learner will watch a video taped using the VITOM camera followed by a short questionnaire. Receives: Other: Video viewing with VITOM |
| 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. Receives: Other: Video viewing with standard handheld high-definition camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study startJun 2016
- Primary completionMar 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- KARL STORZ Endoscopy-America, Inc.
- Responsible party
- Principal investigator, Sean Francis, University of Louisville
- Investigators
- Sean Francis, M.D., Principal investigator, University of Louisville School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120689
- Sponsor's protocol ID
- 16.0002
- Acronym
- VITOM
- Status last verified
- Apr 2019
- First submitted
- 22 Jun 2016
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31169562
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03120689
- Acronym / sponsor ID
- VITOM / 16.0002
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- KARL STORZ Endoscopy-America, Inc.
- Study start
- Jun 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 19 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Live Surgery with VITOM | Active comparator | Other: Live Surgery using VITOMLearner 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 comparator | Other: Live Surgery without VITOMLearner will assist in the traditional manner without the use of the VITOM camera followed by a short questionnaire. |
| Video viewing with VITOM | Active comparator | Other: Video viewing with VITOMLearner will watch a video taped using the VITOM camera followed by a short questionnaire. |
| Video viewing with standard camera | Active comparator | Other: Video viewing with standard handheld high-definition cameraLearner will watch a video taped using the standard hand-held high definition camera followed by a short questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live Surgery using VITOMThe 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. | Other | Live Surgery with VITOM |
| Live Surgery without VITOMThe vaginal operation will not be filmed and learner observation will take place in the traditional way, with them looking at the physical surgical field. | Other | Live Surgery without VITOM |
| Video viewing with VITOMThey will view the 10-minute standardized video filmed with the VITOM® camera. | Other | Video viewing with VITOM |
| Video viewing with standard handheld high-definition cameraThey will view the 10-minute standardized video filmed with the standard, handheld high-definition camera. | Other | Video viewing with standard camera |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Derived from this study: PubMed 31169562Hobson 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.
- Individual participant dataSharing planned: No
Related trials for Pelvic Organ Prolapse
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
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Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
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Suzetrigine Following Urogynecologic Surgery: Investigation of Postoperative Pain Management
Pelvic Organ Prolapse (POP), Postoperative Pain
Active, not recruiting
Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse
Uterine Prolapse
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Clinical Outcomes of Rectopexy for Rectal Prolapse
Rectal Prolapse, Fecal Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Francis, M.D. principal investigator
University of Louisville School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live Surgery using VITOM, Live Surgery without VITOM and Video viewing with VITOM in people with Pelvic Organ Prolapse and Prolapse of Vaginal Vault After Hysterectomy, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Learner satisfaction (time frame: 22 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03120689, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.