Ventral Hernia Clinical Trial
Official title:
Video-based Collaborative Learning to Improve Ventral Hernia Repair
Recent studies demonstrate the critical role of individual surgeon performance, including both the approach they take to an operation as well as their technical skill, in determining patient outcomes. Utilizing the rich data collected by the Abdominal Core Health Quality Collaborative (ACHQC), formerly Americas Hernia Society Quality Collaborative (AHSQC), for its 200 members performing ventral hernia repair in the United States, the investigators will examine the effectiveness of video-based collaborative learning to provide feedback and improve surgical performance and patient outcomes. A prospective randomized trial comparing two interventions is proposed, comparing live video-based surgical coaching and video-based feedback using time-stamped annotations that can be reviewed at a later time to a wait-list control group drawn from the same cohort of surgeons. The results have the immediate potential to improve the quality of care for the 350,000 patients requiring ventral hernia repair each year, while also providing critical evidence to support a novel approach to surgical performance improvement more broadly.
Status | Recruiting |
Enrollment | 54 |
Est. completion date | September 2024 |
Est. primary completion date | January 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - ACHQC membership in good standing - submission of a minimum of 10 eligible cases within the 6 months preceding the time of enrollment in the trial Exclusion Criteria: - not an ACHQC member - not submitting cases to ACHQC within the 6 months preceding the time of enrollment in the trial |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin-Madison | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Augusta University | Abdominal Core Health Quality Collaborative, Agency for Healthcare Research and Quality (AHRQ), University of Wisconsin, Madison |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Technical Skill as Measured by OSATS Score | A repeated measures ANOVA will be used to assess the Objective Structured Assessment of Technical Skills (OSATS) score between the two baseline and two follow-up measures for surgeons randomly assigned to the Coaching and Constructive Feedback intervention arms, as compared with the wait-list control group. The modified OSATS instrument is a validated rubric that assesses a surgeon's overall technical skill. Skill is measured as both a summary score on a scale from 1 (deficient) to 5 (expert), or as a total score across five subdomains (gentleness, tissue exposure, instrument handling, time and motion, flow of operation). Each domain is rated on the same 1 to 5 point Likert scale, leading to overall scores ranging from 5-25. Scoring will continue until a minimum of 15 scores are obtained for each video. | 1 year | |
Primary | Change in Surgical Site Occurrence Rates | The approach to the assessment of change in Surgical Site Occurrence (SSO) rates from baseline to follow-up will be assessed similarly to technical skill; however, in this case longitudinal mixed model Poisson regression will be used, with group assignment as the primary explanatory variable. The data will be examined for over dispersion. SSO is a well-defined measure for ventral hernia repair and a composite measure of several outcomes collected through the ACHQC. This includes surgical site infection, seroma, wound dehiscence, and enterocutaneous fistula. | 1 year | |
Primary | Intervention Adherence: Number of Surgeon Participants who Complete All Requisite Training and Session | Intervention adherence will be assessed as the proportion of surgeon participants in each of the arms that complete all of the requisite training and sessions. Based on previous experience, an estimate of 75% of surgeons will complete all 3 sessions in the real-time coaching arm, while 50% will complete all 3 cases in the Asynchronous Feedback arm. This is the hypothesis based on challenges in prior studies in coordinating stand-alone activities with surgeons. Prior work suggests all surgeons who volunteer will participate in a minimum of one intervention component. | 1 year | |
Secondary | Recurrence Rates at 1 and 2 Years | Another secondary analysis will assess differences in recurrence rates at one and two-years post-intervention, by comparing the Coaching and Constructive Feedback interventions to ACHQC surgeons who are neither surgeons nor coaches in this study. The analysis of long-term follow up is exploratory as a primary analysis would require that we maintain the control group without intervention for 2.5 years to ensure sufficient power, which is not feasible and could adversely impact loss-to- follow-up in the control group. | 2.5 years | |
Secondary | Perceived Value | The perceived value of coaching will be measured at the completion of the intervention by asking coaches and participants to rate on a 1 (low) - 5 (high) scale the perceived value of the intervention in terms of personal performance improvement. Since previous participants have rated the live coaching as highly valuable, we aim to test whether Asynchronous Feedback is perceived to be of significantly lower value than live coaching (non-inferiority, margin of 0.3). | 2.5 years | |
Secondary | Time Efficiency Measured by the Amount of Time Spent in Activities Related to the Program | Coaches and surgeons will log any time spent in activities related to the program in a logbook provided by the study team. Reported time will include time in training, preparing for sessions, reviewing videos, and providing feedback (whether as written asynchronous feedback via Asynchronous Feedback or Live Coaching). The total amount of time spent will be calculated in minutes by coaches and participants for each intervention. This will test a hypothesis that Asynchronous Feedback is less time efficient than live coaching (non-inferiority, margin of 0.5). | 2.5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06016426 -
Mass Closure vs Layer by Layer Closure
|
N/A | |
Recruiting |
NCT05572021 -
A Comparison of the Outcomes in Fortiva and Strattice Mesh
|
N/A | |
Completed |
NCT02292264 -
Risk Factors and Complications of Ventral Hernia Repair
|
||
Completed |
NCT02263625 -
Regional Differences In Indication for Ventral Hernia Repair
|
||
Completed |
NCT02263599 -
Conservative Treatment For Ventral Hernia
|
||
Completed |
NCT01961687 -
A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.
|
N/A | |
Completed |
NCT01325246 -
Reoperation Rate Versus Clinical Recurrence After Ventral Hernia Repair
|
N/A | |
Completed |
NCT03283982 -
Laparoscopic vs. Robotic Ventral Hernia Repair With IPOM
|
N/A | |
Not yet recruiting |
NCT05526209 -
Longitudinal Relaxing Incision as a Technique for Recurrence Prevention in Ventral Hernia
|
||
Completed |
NCT04438369 -
Evaluation of Ultrasound-guided Erector Spinae Block for Postoperative Analgesia in Laprascopic Ventral Hernia Repair.
|
N/A | |
Recruiting |
NCT02703662 -
Performance of Biologic Mesh Materials in Abdominal Wall Reconstruction
|
Phase 2/Phase 3 | |
Completed |
NCT03938688 -
Randomized Control Trial Comparing Transfascial Suture for Mesh Fixation to No Mesh Fixation
|
N/A | |
Completed |
NCT01719718 -
The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair
|
N/A | |
Completed |
NCT03342040 -
Transverse Abdominis Plane Block in Laparoscopic Ventral Hernia Repair
|
N/A | |
Completed |
NCT04150796 -
Comparing eTEP and Laparoscopic Intraperitoneal Onlay Mesh (IPOM) for Ventral Hernias
|
N/A | |
Recruiting |
NCT03222102 -
Ventral Hernia Prevention After Liver Transplantation
|
N/A | |
Completed |
NCT05610267 -
Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair
|
||
Terminated |
NCT01794338 -
The Use of Biologic Mesh vs Bioabsorbable Mesh During Ventral Hernia Repair in At-risk Patients
|
N/A | |
Completed |
NCT01886963 -
A Clinical Trial Using Spy Elite System in Planning Tissue Advancement Flaps After Ventral Hernia Repair
|
N/A | |
Terminated |
NCT03429374 -
Tacks Versus Glue for Mesh Fixation in Laparoscopic Ventral Hernia Repair Treating Defects Between 2 and 5 cm Width
|
N/A |