Ventral HerniaNCT04173884
Video-based Collaborative Learning to Improve Ventral Hernia Repair
A study testing Coaching and Constructive Feedback in people with Ventral Hernia, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Coaching and Constructive Feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 30 Jun 2025
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- not an ACHQC member
- not submitting cases to ACHQC within the 6 months preceding the time of enrollment in the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53792-1690
About this study
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.
Read the detailed description
Hernias of the abdominal wall are among the most common surgical disorders, with over 350,000 patients requiring repair annually for a total cost of $3.2 billion. Despite their prevalence, outcomes remain poor and variable, with recurrence rates that range between 32% and 63% at 10 years and a 5-fold difference in recurrence rates between surgeons. With the introduction of new repair techniques and continuous advances in biomedical devices and technology, it is difficult for practicing surgeons to stay abreast of new developments and incorporate these advances into their practice. Collaborative learning through video review can support continuous professional development and aid practicing surgeons in adopting new approaches and continually improving their own technical skills.
Surgeons have limited time to invest in surgical quality improvement despite recognizing its importance. A critical gap in our current knowledge is the optimal approach to video-based collaborative learning. The effectiveness of two approaches to video review and performance feedback are herein proposed to be compared: synchronous surgical coaching versus asynchronous feedback. This study will be performed in partnership with the Abdominal Core Health Quality Collaborative (ACHQC), formerly Americas Hernia Society Quality Collaborative (AHSQC). This name change took place in July 2020. Surgeons will be paired with a coach and will participate in collaborative review of ventral hernia repairs. Participants will be randomized to undergo in-person coaching or asynchronous feedback utilizing a web-based video platform or will be assigned to a wait-list control group. All participants will submit 2 procedural videos pre- and post-intervention for self-assessment and blinded expert review utilizing a previously validated assessment instrument to measure technical skill. The primary outcome is change in 30-day procedural outcomes, which are captured and risk adjusted in the ACHQC. Participants will be followed for 2 years to assess long-term recurrence rates. Other secondary outcomes include intervention adherence, time spent in review, and the perceived value of the different approaches.
These interventions will have immediate impact. Working with the ACHQC, the potential exists to improve quality and decrease costs for the 350,000 patients that require a ventral hernia repair annually. In addition, this will provide a new paradigm for surgical quality improvement and continuing professional development.
- Conditions
- Ventral Hernia
- Being tested
- Coaching, Constructive Feedback
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoachingOther
Surgical coaching is based on a peer coaching model that has been proven to be highly effective in other disciplines and for surgeons in training. Surgical coaching can improve technical performance in one of two ways: 1) identifying new or alternative approaches to the procedure; or 2) improving surgeon technical skill, which can lead to improvements in patient outcomes. In this proposal, our primary objective is to evaluate the effectiveness of video-based collaborative learning for surgeons.
Constructive FeedbackOther
Constructive feedback is critical for performance improvement. It is currently unknown, however, whether asynchronous constructive feedback alone, without interactive discussions with a coach, would be as acceptable and valued as formal in-person coaching. Furthermore, the effectiveness of either approach to collaborative learning in improving surgical performance and outcomes is not known.
| Study group | Role | What they receive |
|---|---|---|
| Live Surgical Peer Coaching | Active comparator | Coaches will facilitate an initial, individual, introductory phone call with participants prior to the first formal coaching session. The objective of this call is to develop rapport, explore each other's background, experience, and motivation for participation in the program, set overall goals for the program, set specific goals for the first coaching session, develop an action plan including identification of the key characteristics of the first case for review, and develop a timeline and plan for meetings. Peer coaching sessions will be scheduled at three national meetings that are commonly attended by ACHQC surgeons. In advance of each meeting, participants will record and upload a self-selected video to a secure server maintained by the study team, and coaches will have the opportunity to review the video if they wish to prepare. A live coaching session will be organized at the meeting where the coaches and participants will have parallel one-hour coaching sessions. Receives: Other: Coaching |
| Asynchronous Video-based Constructive Feedback | Active comparator | There will be no real-time interpersonal contact between coaches and participants in this arm. Participants will upload their self-selected procedural video to the video review platform, together with a short description of the case and any specific questions. The coach will review the video within one week of its posting and provide time-stamped feedback on the video platform. Participants will then review the coach's feedback within one week with the ability to respond to the comments. The coach and participant will continue communication via the internet-based review platform until no further comments are made by either party. Coach-participant dyads are expected to review three videos during the 6 month intervention period. Receives: Other: Constructive Feedback |
| Wait-List Control | Active comparator | One-third of participants will be randomized to an intervention, but wait-listed to provide a control group. These surgeons will submit two videos for technical skill evaluation during each of the baseline and follow-up periods, and ACHQC data will be tracked for short-term outcomes prior to their crossover to the intervention for long-term follow-up. Selecting the control group using the identical sampling frame of ACHQC surgeons participating in the interventions affords the opportunity for a comparable group with outcome metrics recorded systematically. Receives: Other: Coaching; Other: Constructive Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
Secondary outcomes (3)
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.
Measured: 2.5 years
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).
Measured: 2.5 years
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).
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start1 Sep 2019
- Primary completion31 May 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniaStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), University of Wisconsin, Madison, Abdominal Core Health Quality Collaborative
- Responsible party
- Sponsor
- Investigators
- Caprice C Greenberg, MD MPH, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173884
- Sponsor's protocol ID
- 22-2309
- Other IDs
- A539713, SMPH/SURGERY/SURG ONC, 1R01HS025989-01, Protocol Version 3/1/2019
- Status last verified
- Aug 2021
- First submitted
- 20 Nov 2019
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video-based Collaborative Learning to Improve Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT04173884
- Acronym / sponsor ID
- 22-2309
- Conditions
- Ventral Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), University of Wisconsin, Madison, Abdominal Core Health Quality Collaborative
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 22 Nov 2019 (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.
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.
Detailed description
Hernias of the abdominal wall are among the most common surgical disorders, with over 350,000 patients requiring repair annually for a total cost of $3.2 billion. Despite their prevalence, outcomes remain poor and variable, with recurrence rates that range between 32% and 63% at 10 years and a 5-fold difference in recurrence rates between surgeons. With the introduction of new repair techniques and continuous advances in biomedical devices and technology, it is difficult for practicing surgeons to stay abreast of new developments and incorporate these advances into their practice. Collaborative learning through video review can support continuous professional development and aid practicing surgeons in adopting new approaches and continually improving their own technical skills.
Surgeons have limited time to invest in surgical quality improvement despite recognizing its importance. A critical gap in our current knowledge is the optimal approach to video-based collaborative learning. The effectiveness of two approaches to video review and performance feedback are herein proposed to be compared: synchronous surgical coaching versus asynchronous feedback. This study will be performed in partnership with the Abdominal Core Health Quality Collaborative (ACHQC), formerly Americas Hernia Society Quality Collaborative (AHSQC). This name change took place in July 2020. Surgeons will be paired with a coach and will participate in collaborative review of ventral hernia repairs. Participants will be randomized to undergo in-person coaching or asynchronous feedback utilizing a web-based video platform or will be assigned to a wait-list control group. All participants will submit 2 procedural videos pre- and post-intervention for self-assessment and blinded expert review utilizing a previously validated assessment instrument to measure technical skill. The primary outcome is change in 30-day procedural outcomes, which are captured and risk adjusted in the ACHQC. Participants will be followed for 2 years to assess long-term recurrence rates. Other secondary outcomes include intervention adherence, time spent in review, and the perceived value of the different approaches.
These interventions will have immediate impact. Working with the ACHQC, the potential exists to improve quality and decrease costs for the 350,000 patients that require a ventral hernia repair annually. In addition, this will provide a new paradigm for surgical quality improvement and continuing professional development.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Live Surgical Peer Coaching | Active comparator | Other: CoachingCoaches will facilitate an initial, individual, introductory phone call with participants prior to the first formal coaching session. The objective of this call is to develop rapport, explore each other's background, experience, and motivation for participation in the program, set overall goals for the program, set specific goals for the first coaching session, develop an action plan including identification of the key characteristics of the first case for review, and develop a timeline and plan for meetings. Peer coaching sessions will be scheduled at three national meetings that are commonly attended by ACHQC surgeons. In advance of each meeting, participants will record and upload a self-selected video to a secure server maintained by the study team, and coaches will have the opportunity to review the video if they wish to prepare. A live coaching session will be organized at the meeting where the coaches and participants will have parallel one-hour coaching sessions. |
| Asynchronous Video-based Constructive Feedback | Active comparator | Other: Constructive FeedbackThere will be no real-time interpersonal contact between coaches and participants in this arm. Participants will upload their self-selected procedural video to the video review platform, together with a short description of the case and any specific questions. The coach will review the video within one week of its posting and provide time-stamped feedback on the video platform. Participants will then review the coach's feedback within one week with the ability to respond to the comments. The coach and participant will continue communication via the internet-based review platform until no further comments are made by either party. Coach-participant dyads are expected to review three videos during the 6 month intervention period. |
| Wait-List Control | Active comparator | Other: Coaching, Other: Constructive FeedbackOne-third of participants will be randomized to an intervention, but wait-listed to provide a control group. These surgeons will submit two videos for technical skill evaluation during each of the baseline and follow-up periods, and ACHQC data will be tracked for short-term outcomes prior to their crossover to the intervention for long-term follow-up. Selecting the control group using the identical sampling frame of ACHQC surgeons participating in the interventions affords the opportunity for a comparable group with outcome metrics recorded systematically. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- not an ACHQC member
- not submitting cases to ACHQC within the 6 months preceding the time of enrollment in the trial
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 |
|---|---|---|
| CoachingSurgical coaching is based on a peer coaching model that has been proven to be highly effective in other disciplines and for surgeons in training. Surgical coaching can improve technical performance in one of two ways: 1) identifying new or alternative approaches to the procedure; or 2) improving surgeon technical skill, which can lead to improvements in patient outcomes. In this proposal, our primary objective is to evaluate the effectiveness of video-based collaborative learning for surgeons. | Other | Live Surgical Peer Coaching, Wait-List Control |
| Constructive FeedbackConstructive feedback is critical for performance improvement. It is currently unknown, however, whether asynchronous constructive feedback alone, without interactive discussions with a coach, would be as acceptable and valued as formal in-person coaching. Furthermore, the effectiveness of either approach to collaborative learning in improving surgical performance and outcomes is not known. | Other | Asynchronous Video-based Constructive Feedback, Wait-List Control |
Primary outcome
Change in Technical Skill as Measured by OSATS Score
Time frame: 1 year
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.
Change in Surgical Site Occurrence Rates
Time frame: 1 year
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.
Intervention Adherence: Number of Surgeon Participants who Complete All Requisite Training and Session
Time frame: 1 year
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.
3 secondary outcomes
Recurrence Rates at 1 and 2 Years
Time frame: 2.5 years
Perceived Value
Time frame: 2.5 years
Time Efficiency Measured by the Amount of Time Spent in Activities Related to the Program
Time frame: 2.5 years
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 10 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Caprice C Greenberg, MD MPH principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coaching and Constructive Feedback in people with Ventral Hernia, run by University of North Carolina, Chapel Hill 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 10 Nov 2025. 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?
Change in Technical Skill as Measured by OSATS Score (time frame: 1 year). The study lists 3 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 10 Nov 2025.