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Surgical EducationCSATSNCT02986217

The Effect of Structured Feedback on Live Surgical Performance

A study testing regular structured assessment of surgical performance in people with Surgical Education, run by George Washington University.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study seeks to establish the effect of regular structured feedback on surgical performance using crowd sourced video assessments with validated objective performance scores and time to complete a specific surgical procedure through a randomized controlled trial. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Surgical Education
What is being tested?
regular structured assessment of surgical performance
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
No sites listed yet
Study dates
Dec 2016to Feb 2019
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 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • current position as a resident in obstetrics and gynecology in a year of training where laparoscopic or robotic hysterectomy is regularly performed -- OR -- FMIGS Fellow regularly performing laparoscopic or robotic hysterectomy
  • participants must be between 18 and 60 years of age

Who cannot join

  • persons not in a position as a resident in obstetrics and gynecology in a year of training where laparoscopic or robotic hysterectomy is regularly performed -- OR -- persons not a FMIGS Fellow regularly performing laparoscopic or robotic hysterectomy
  • participants younger than 18 and older than 60 years of age

About this study

Official title: The Effect of Structured Feedback on Live Surgical Performance: A Single-Blind Randomized Control Trial

This study seeks to establish the effect of regular structured feedback on surgical performance using crowd sourced video assessments with validated objective performance scores and time to complete a specific surgical procedure through a randomized controlled trial. The working hypothesis is that regular structured assessment will lead to a greater measurable improvement in performance, as defined by objective performance scores, than will traditional feedback methods.

Read the detailed description

The American Association of Gynecologic Laparoscopists (AAGL) and Accreditation Council of Graduate Medical Education (ACGME) have endeavored to implement structure and standardization for the fellowship in minimally invasive gynecologic surgical programs (FMIGS) and obstetric and gynecology residency programs respectively. Educational objectives are explicitly delineated. Though the fellowship and residency educational objectives are well rounded, and include the development of skills to become leaders and educators in the field of minimally invasive gynecologic surgery (MIGS) and general obstetrics and gynecology, one of the main objective of the fellowship and residency training is the attainment of surgical skill. This is ensured by a requirement for a breadth of surgical exposure including vaginal surgery, hysteroscopy, traditional laparoscopy, management of surgical complications, minimally invasive hysterectomy, urogynecologic procedures, gastrointestinal surgery, urinary tract surgery, reproductive surgery, and the surgical management of common gynecologic conditions such as endometriosis. Minimum case requirements have been implemented to provide guidance for FMIGS and residency programs. In addition, trainees are required to log surgical cases and this information is utilized for FMIGS and residency program site inspections as well as for feedback of surgical competency. Despite standardization efforts by the AAGL and ACGME, the FMIGS and obstetric and gynecology residency curriculums are still in evolution. There is likely still great variation in surgical exposure between programs. In addition, though regular feedback is a requirement of training programs, the process is likely unstructured and subjective; based on case logs, self-assessments, and feedback by faculty surgeons. There is thus a critical need to develop a standardized, objective, timely, and actionable feedback methodology to facilitate program oversight and ensure FMIGS fellows and obstetrics and gynecology residents are achieving surgical competency throughout their training. In the absence of such structured feedback models, it will remain difficult to optimize FMIGS fellowship and obstetrics and gynecology resident training, and provide objective measurements of the impact of such training on surgical performance and patient outcomes. .

The long-term goal of this study is to assist in developing methods for surgical assessment that facilitate program oversight, allow fellows, residents, and program directors to identify specific skill sets in need of improvement, monitor progress in skill acquisition, and clearly and objectively document achievement of milestones throughout training. The study's overall objective is to determine how consistent structured feedback using crowd sourcing impacts time to complete a task as well as surgical performance as measured by GOALS and GEARS scores. The central hypothesis is that fellows and residents who receive consistent structured feedback over a sustained period of time will have shorter task times, overall improved performance, and greater satisfaction than fellows and residents receiving traditional feedback. The rationale for this work is that it will provide focus and supportive data for large-scale studies of surgical skill acquisition and development.

This study seeks to establish the effect of regular structured feedback on surgical performance using crowd sourced video assessments with GOALS and GEARS through a randomized controlled trial. The study hypothesizes regular structured assessment will lead to a greater measurable improvement in performance, as defined by change and GOALS and GEARS scores, than will traditional feedback methods as well as time to complete a specific procedure.

Being tested
regular structured assessment of surgical performance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • regular structured assessment of surgical performanceOther

Study groups in NCT02986217
Study groupRoleWhat they receive
Control GroupNo interventionParticipants randomized to the Control Group will submit a video of surgical performance of vaginal cuff closure during a hysterectomy. Subjects in the control group will receive traditional feedback methods as determined by each participant's training program. Subjects in the control group will repeat the process of video submission of the same procedure using the same surgical approach every 2 weeks for 2 cycles. At 6 weeks, participants will submit a final video performing vaginal cuff closure during hysterectomy.
Experimental GroupExperimentalParticipants randomized to the Experimental Group will submit a video of surgical performance of vaginal cuff closure during a hysterectomy. Subjects in the experimental group will then receive feedback within 5 business days of video submission and repeat the process of video submission of the same procedure using the same surgical approach every 2 weeks for 2 cycles. At 6 weeks, participants will submit a final video performing vaginal cuff closure during hysterectomy.
Receives: Other: regular structured assessment of surgical performance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. difference in mean time needed to perform cuff closure during hysterectomy

    The difference in mean time (measured in minutes) needed to perform vaginal cuff closure during hysterectomy between subjects in the control versus experimental groups.

    Measured: 6 weeks post study enrollment

  2. difference in mean surgical performance score

    The difference in mean surgical performance score of a vaginal cuff closure at the time of hysterectomy between participants in the control versus experimental groups.

    Measured: 6 weeks post study enrollment

Secondary outcomes (1)
  1. difference in trainee satisfaction with feedback method

    the difference in mean satisfaction score between participants in the control versus experimental groups

    Measured: 6 weeks post study enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionFeb 2019
  4. Study completionFeb 2019

Why it stopped: PI Left institution and did not transfer study to another PI

Resources

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
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02986217
Sponsor's protocol ID
101614
Acronym
CSATS
Status last verified
Oct 2022
First submitted
6 Dec 2016
Last updated
25 Oct 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing regular structured assessment of surgical performance in people with Surgical Education, run by George Washington University.

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: stopped early, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

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 was stopped early (reason given: PI Left institution and did not transfer study to another PI). Results are not available in the source record.

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?

difference in mean time needed to perform cuff closure during hysterectomy (time frame: 6 weeks post study enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 25 Oct 2022.

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