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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02669537
Other study ID # GoPro
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date May 2016
Est. completion date December 2017

Study information

Verified date May 2022
Source University Hospitals Cleveland Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Utilization of the GoPro camera to facilitate vaginal surgical education among residents and medical students


Description:

Surgical Skills Assessment: Resident Control Group (Routine Educational Practice): Participants in this group will be exposed to routine surgical education as practiced at University Hospitals Case Medical Center, Department of OB/Gyn. This includes real time instruction at the time of surgery for the resident trainee performing all or part of the procedure as appropriate for their level of training. The resident may use any teaching tools before or after the surgery including online surgical videos, a surgical atlas or textbook. Immediately after the procedure the attending surgeon will evaluate the trainee using a validated 13-item Vaginal Surgical Skills Index (VSSI) form and the 7-item Global Rating Scale of Operative Performance (GRS) . The use of this scale is also part of standard surgical educational practice. The trainee will then perform an additional procedure of the same type within a 4 week period (the average duration of a rotation) and again undergo evaluation using the VSSI form by the attending surgeon. This is again part of routine educational practice in order to monitor progression of surgical skills. Resident GoPro Group: Participants assigned this group will perform or assist with the procedure based on level of training and experience, as is usual practice in the residency training program. The resident surgeon will be wearing the camera (GoPro Hero 3) during the procedure. This is not part of routine practice. Immediately after the procedure the attending surgeon will evaluate the trainee using the VSSI and GRS forms. The trainee will then have a chance to review the video of their surgery with the attending surgeon within a 14-day period. The trainee will then perform a 2nd procedure of the same type within a 4 week period (the average duration of a rotation) and again undergo evaluation using the VSSI form by the attending surgeon. It is common for residents to perform a type of procedure (cerclage, culdoplasty, vaginal hysterectomy, etc.) many times during a rotation. However, for the purpose of the research study, we will only be comparing the change in the VVSI score between 2 procedures. In both groups, surgical assistants will be instructed not to automatically assist but to wait for the participant to instruct them on what assistance they require. The surgical skills inventory will be marked by the participant with their numerical designation and will then be placed in a locked box in the pre-operative area of the Humphrey operating room suite. These will be collected by the study investigators at the end of each week. The key to the box will be kept in a locked cabinet in Amy Schmidt's office on the 5th floor of MacDonald Women's Hospital. Medical Student Evaluation of the OR Experience: Medical students will be able to watch surgeries in real time using the GoPro App which will be downloaded to an iPad specifically purchased for use in this study. The video will be streamed over the secure UH BOYD network with both the surgeon and medical student are in the same operating room. The GoPro App does not allow the video to be saved to the iPAD. At the end of each surgery medical student participants will be given a short survey with how satisfied they were with the level of teaching in the operating room (Appendix 3). The survey will be marked by the participant with their numerical designation and will then be placed in a locked box in the pre-operative area of the Humphrey operating room suite. These will be collected by the study investigators at the end of each week. The key to the box will be kept in a locked cabinet in Amy Schmidt's office on the 5th floor of MacDonald Women's Hospital. The results of the survey will be compared between those students viewing the surgery on the GoPro App and to those who are participating in the surgery without the GoPro camera. The survey is not routine educational practice, however, surveys are often employed in our department to gauge medical student attitudes. Additionally all students who do not initially view a surgery with the GoPro app (those in the control group and those who choose not to participate in the research study) will be given the opportunity to use the GoPro app during a different surgery. Acquisition of Surgical Video: Patients will be informed that the surgery will be recorded using a recording device and, if the patient chooses to allow recording, informed consent will be obtained using the standard image release consent form from UHCMC The video recording will not include any patient identifiers or markings.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2017
Est. primary completion date July 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - - Resident physician volunteers (PGY 1-4) currently in the OB/Gyn residency training program at University Hospitals Case Medical Center - Medical student volunteers (MS1-MS4) currently enrolled at the Case Western Reserve University School of Medicine, Cleveland Clinic Lerner College of Medicine, or on an Ob/Gyn away rotation at the University Hospitals Case Medical Center Exclusion Criteria: - - Trainees who do not volunteer or do not wish to participate in the study

Study Design


Related Conditions & MeSH terms


Intervention

Device:
GoPro Camera
The gopro camera will be used to record the procedure which will be reviewed by the resident prior to performing a second procedure of the same type.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospitals Cleveland Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Change in surgical skill score using the Vaginal Surgical Skills Inventory (VVSI) Assessment of change in score between 2 consecutive procedures using the GoPro camera, compared to surgeons who did not use the camera 12 months
Primary Change in score using the Global Rating Scale (GRS) Assessment of change in score between 2 consecutive procedures using the GoPro camera, compared to surgeons who did not use the camera 12 months
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