- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05911165
Impact of Surgical Coaching on Resident ObGyn Laparoscopic Skills
Evaluating the Impact of Video-based Surgical Coaching on Obstetrics and Gynecology Residents' Laparoscopic Suturing Skills
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
During the twelve-month study period, all participants will have access to an instructional video related to laparoscopic vaginal cuff suturing and the laparoscopic vaginal cuff trainer in order to practice laparoscopic suturing as desired. All participants will keep a log of voluntary practice time on the vaginal cuff trainer. These resources will constitute the control arm of the study.
Participants randomized to the surgical coaching arm (coachees) will also receive three video-based coaching sessions over the course of a twelve-month study period focused on laparoscopic suturing. Surgical coaches will include attendings and gynecologic surgery fellows who are comfortable incorporating laparoscopic suturing of the vaginal cuff at the time of hysterectomy into their own practice. The coaches participating in this study will also be listed as investigators. Surgical coaching sessions will include 30-60 minute meetings in which the coach-coachee pair reviews recorded laparoscopic suturing practice sessions to examine different aspects of surgical performance. The coachee will be responsible for providing a video of their own practice of laparoscopic vaginal cuff closure techniques which may occur in a simulation lab utilizing the validated cuff model or in the operating room. At the Cleveland Clinic, all laparoscopic surgeries at Main Campus are recorded and saved on a secure database in the cloud. Surgeries at the regional campuses, including Hillcrest, Fairview, and South Pointe are also saved on a secure tower within the operating room. These videos are taken from the laparoscopic camera and only show the operative field, without any patient identifying information. These videos are stored and commonly used for surgical review, education, and research purposes. Residents will have access to the intraoperative recordings for which they performed laparoscopic suturing. These videos will be utilized for review during the surgical coaching sessions. Additionally, at the beginning of each coaching session, individualized goals will be set by the coachee in order to facilitate discussion during the session. At the end of each session, the coachee will determine a personal action plan for which they will focus until the following coaching session. As part of the surgical coaching method, the goals and action planning are determined by the coachee based on their specific needs, with help of the coach.
All research will take place within the Women's Health Institute. Coaching sessions will be performed in a quiet and private setting where the only participants are the coach/coachee pair.
Comparison:
- Instructional video of laparoscopic vaginal cuff suturing
- Participants will have access to the laparoscopic vaginal cuff trainer in order to practice laparoscopic suturing as desired
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
-Cleveland Clinic Ob/Gyn Resident
Exclusion Criteria:
-None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control group
Resident participants who do not receive video-based surgical coaching
|
During the twelve-month study period, all participants will have access to an instructional video related to laparoscopic vaginal cuff suturing and the laparoscopic vaginal cuff trainer in order to practice laparoscopic suturing as desired.
All participants will keep a log of voluntary practice time on the vaginal cuff trainer.
These resources will constitute the control arm of the study
|
Experimental: Comparison group
Resident participants who do receive video-based surgical coaching
|
Surgical coaching sessions will include 30-60 minute meetings in which the coach-coachee pair reviews recorded laparoscopic suturing practice sessions to examine different aspects of surgical performance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global Operative Assessment Laparoscopic Skills (GOALS-PLUS)
Time Frame: 1-day
|
Video-based review of intraoperative vaginal cuff closure performed by the resident utilizing GOALS-Plus on a scale of 0 (worst score) to 40 (best score)
|
1-day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surgical Confidence
Time Frame: 1-day
|
Participant reported confidence in their laparoscopic surgery skills on a 5 point Likert scale of 1 (very unconfident) to 5 (very confident)
|
1-day
|
Surgical Confidence
Time Frame: 1 day
|
Participant reported confidence in their ability to perform laparoscopic cuff closure on a 5 point Likert scale of 1 (very unconfident) to 5 (very confident)
|
1 day
|
Enjoyment in the operating room
Time Frame: 1 day
|
Participant reported enjoyment in the operating room on a 5 point Likert scale of 1 (very much do not enjoy) to 5 (very much enjoy)
|
1 day
|
Plans to incorporate surgery into career
Time Frame: 1 day
|
Participant reported plans to incorporate surgery into their attending practice on a 4 point Likert scale of 1 (no surgery at all) to 4 (primarily surgery)
|
1 day
|
Amount of tracking months
Time Frame: 1 day
|
Participant reported time spent tracking with a gynecologic surgical subspecialty on a 4 point Likert scale of 1(0 months) to 4 (>3 months)
|
1 day
|
Surgical experience
Time Frame: 1 day
|
Participant reported number of times they have performed a laparoscopic vaginal cuff closure on a 4 point Likert scale of 1 (never) to 4 (>10 times)
|
1 day
|
Time spent watching instructional videos
Time Frame: 1 day
|
Participant reported amount of time spent watching instructional videos on a 5 point Likert scale of 1 (no time) to 5 (>5 hours)
|
1 day
|
Time spent watching personal surgical videos
Time Frame: 1 day
|
Participant reported amount of time spent watching personal surgical videos on a 5 point Likert scale of 1 (no time) to 5 (>5 hours)
|
1 day
|
Time spent practicing on simulation model
Time Frame: 1 day
|
Participant reported amount of time spent practicing vaginal cuff closure on the simulation model on a 5 point Likert scale of 1 (no time) to 5 (>5 hours)
|
1 day
|
Experience undergoing surgical coaching
Time Frame: 1 day
|
Participant reported enjoyment as a coachee undergoing surgical coaching (if applicable) on a 5 point Likert scale of 1(very much enjoyed) to 5 (very much did not enjoy)
|
1 day
|
Experience undergoing surgical coaching
Time Frame: 1 day
|
Participant reported helpfulness of surgical coaching for the advancement of their laparoscopic vaginal cuff closure skills on a 5 point Likert scale of 1 (very helpful) to 5 (very unhelpful)
|
1 day
|
Experience undergoing surgical coaching
Time Frame: 1 day
|
Participant reported likelihood of recommending surgical coaching to a colleague on a 5 point Likert scale of 1 (very likely) to 5 (very unlikely)
|
1 day
|
Sport confidence assessment instrument
Time Frame: 1 day
|
Series of questions asking participants to compare their self-confidence to the most confident surgeon they know.
Questions are ranked on a 9 point Likert scale of 1 (low) to 9 (high).
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cara King, D.O., The Cleveland Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 22-836
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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