Quality of life among older patients after elective ventral hernia repair: A retrospective review.

BACKGROUND: Ventral hernia repair is a common elective general surgery procedure among older patients, a population at greater risk of complications. Prior research has demonstrated improved quality of life in this population despite increased risk of complications. This study sought to assess the relationship between post-ventral hernia repair quality of life and patient frailty. We hypothesized that frail patients would report smaller gains in quality of life compared to the non-frail group. METHODS: The Abdominal Core Health Quality Collaborative was used to identify a cohort of patients 65 years of age or older undergoing elective ventral hernia repair from 2018 to 2022. Patients were categorized based on their modified frailty index scores as not frail/prefrail, frail, and severely frail. Quality of life was assessed using a patient-reported 12-item scale preoperatively, 30 days, 6 months, and 1 year postoperatively. RESULTS: A total of 3,479 patients were included: 30.93% non-frail, 47.17% frail, and 21.90% severely frail. Severely frail patients had lower quality of life scores at baseline (P = .001) but reported higher quality of life at both 30 days (1.24 points higher, 95% confidence interval (-1.51, 2.52), P = .010) and 6 months (0.92 points higher, 95% confidence interval (-2.29, 4.13), P = .005). Severely frail patients had higher rates of surgical site complications (P < .001) but no difference in 30-day readmissions. CONCLUSION: Our results found that frail patients reported the greatest increase in quality of life 1 year from baseline, showing that they, when selected appropriately, can gain equal benefits and have similar surgical outcomes as their non-frail counterparts.

Outcomes and quality of life of frail patients following elective ventral hernia repair: Retrospective review of a national hernia collaborative.

BACKGROUND: Ventral hernia repair (VHR) is one of the most common general surgery procedures among older adults but is often deferred due to a higher risk of complications. This study compares postoperative quality of life (QOL) and complications between frail and non-frail patients undergoing elective VHR. We hypothesized that frail patients would have higher complication rates and smaller gains in quality of life compared to non-frail patients. STUDY DESIGN: Patients 65 years of age and older, undergoing elective VHR between 2018 and 2022 were selected from the ACHQC (Abdominal Core Health Quality Collaborative) and grouped based on frailty scores obtained using the Modified Frailty Index (mFI-5). Logistic regression adjusting for hernia characteristics (size, recurrent, parastomal, incisional) were performed for 30-day outcomes including surgical site infections (SSI), surgical site occurrences (SSO), surgical site infections/occurrences requiring procedural intervention (SSOPI), and readmission. Multivariable analyses controlling for patient and procedure characteristics were performed comparing QOL scores (HerQLes scale, 0-100) at baseline, 30 days, 6 months and 1 year postoperatively. RESULTS: A total of 4888 patients were included, 29.17% non-frail, 47.87% frail, and 22.95% severely frail. On adjusted analysis, severely frail patients had higher odds of SSO (most commonly seroma formation) but no evidence of a difference in SSI, SSOPI, readmission or mortality. Severely frail patients had lower median QOL scores at baseline (48.3/100, IQR 26.1-71.7, p â€‹= â€‹0.001) but reported higher QOL scores at both 30-days (68.3/100, IQR 41.7-88.3, p â€‹= â€‹0.01) and 6-months (86.7/100, IQR 65.0-93.3, p â€‹= â€‹0.005). CONCLUSION: Severely frail patients reported similar increases in QOL and similar complications to their not frail counterparts. Our results demonstrate that appropriately selected older patients, even those who are severely frail, may benefit from elective VHR in the appropriate clinical circumstance.

Individuals with a ventral hernia who report moderate to high fear have worse functional performance than those with low fear.

PURPOSE: Ventral hernia repairs (VHR) are performed to restore the integrity of the abdominal wall. Fear of movement, or kinesiophobia, may develop in patients with ventral hernia due to pain and functional impairments, however it has not yet been objectively measured in this patient population. The purpose of this study was to test the hypothesis that in patients with ventral hernia awaiting surgical repair, higher levels of kinesiophobia would be associated with poorer mobility, abdominal core function, and quality of life. METHODS: Seventy-seven participants scheduled for ventral hernia repair were enrolled as part of an ongoing randomized controlled trial (NCT05142618). The Tampa Scale of Kinesiophobia (TSK-11) is an 11-item questionnaire that asks about fear of movement and physical activity restriction. Participants were split into groups based on their TSK-11 score (minimal, low, moderate to high). Primary outcome measures included the five-time sit-to-stand (5xSTS), Quiet Unstable Sitting Test (QUeST), and the Hernia-Related Quality-of-Life (HerQLeS) survey. A one-way ANOVA with a Bonferroni correction compared QUeST, 5xSTS, and HerQLes results between groups. RESULTS: Groups were significantly different on 5xSTS (minimal: 11.4 ± 2.6 s, low: 13.8 ± 3.1 s, moderate to high: 17.8 ± 9.8 s; p = 0.001) and HerQLes (minimal: 58.0 ± 27.8, low: 49.4 ± 22.0, moderate to high: 30.6 ± 25.3; p = 0.003) but not QUeST (minimal: - 2.8 ± 2.5, low: - 6.8 ± 10.0, moderate to high: - 5.5 ± 5.0; p = 0.16). CONCLUSION: Individuals with moderate to high kinesiophobia have worse pre-operative performance-based (5xSTS) and self-reported (HerQLes) function and quality of life than those with minimal and low kinesiophobia. Future research should examine the influence of kinesiophobia on post-operative outcomes as it may be a potent target for rehabilitation.

Reducing the incidence of surgical site infection after ventral hernia repair: Outcomes from the RINSE randomized control trial.

BACKGROUND: The clinical and financial impact of surgical site infection after ventral hernia repair is significant. Here we investigate the impact of dual antibiotic irrigation on SSI after VHR. METHODS: This was a multicenter, prospective randomized control trial of open retromuscular VHR with mesh. Patients were randomized to gentamicin â€‹+ â€‹clindamycin (G â€‹+ â€‹C) (n â€‹= â€‹125) vs saline (n â€‹= â€‹125) irrigation at time of mesh placement. Primary outcome was 30-day SSI. RESULTS: No significant difference was seen in SSI between control and antibiotic irrigation (9.91 vs 9.09 â€‹%; p â€‹= â€‹0.836). No differences were seen in secondary outcomes: SSO (11.71 vs 13.64 â€‹%; p â€‹= â€‹0.667); 90-day SSO (11.1 vs 13.9 â€‹%; p â€‹= â€‹0.603); 90-day SSI (6.9 vs 3.8 â€‹%; p â€‹= â€‹0.389); SSIPI (7.21 vs 7.27 â€‹%, p â€‹= â€‹0.985); SSOPI (3.6 vs 3.64 â€‹%; p â€‹= â€‹0.990); 30-day readmission (9.91 vs 6.36 â€‹%; p â€‹= â€‹0.335); reoperation (5.41 vs 0.91 â€‹%; p â€‹= â€‹0.056). CONCLUSION: Dual antibiotic irrigation with G â€‹+ â€‹C did not reduce the risk of surgical site infection during open retromuscular ventral hernia repair.

The impact of opioid versus non-opioid analgesics on postoperative pain level, quality of life, and outcomes in ventral hernia repair.

PURPOSE: Managing postoperative pain remains a significant challenge in hernia operations. With ventral hernia repair (VHR) being one of the most commonly performed procedures, this study aimed to compare the effectiveness of non-opioid analgesia to opioid-based regimens for postoperative pain management. METHODS: The Abdominal Core Health Quality Collaborative was queried for elective VHR patients between 2019-2022. Subjects prescribed opioid or non-opioid analgesics at discharge were matched using a propensity score. Postoperative Hernia-Related Quality of Life Survey (HerQLes) summary scores, Patient-Reported Outcome Measurement Information System (PROMIS) 3a questionnaire, and clinical outcomes were compared between the two groups. RESULTS: 1,051 patients who underwent VHR met the study criteria. The 2:1 matched demographics were opioids (n = 188) and non-opioids (n = 94) (median age 63, 48% females, 91% white, and 6.5 cm hernia length). Long-term (1-year post-operation) patients' pain levels were similar between opioids vs non-opioids (median (IQR): 31(31-40) vs. 31(31-40), p = 0.46), and HerQLes summary scores were similar (92(78-100) vs. 90(59-95), p = 0.052). Clinical short-term (30-days post-operation) outcomes between opioid vs non-opioid patients had similar length-of-stay (1(0-5) vs 2(0-6), P = 0.089), readmissions (3% vs. 1%, P = 0.28), recurrences (0% vs. 0%, P = 1), reoperations (1% vs. 0%, P = 0.55), surgical site infections (3% vs. 7%, P = 0.11), surgical site occurrences (5% vs. 6%, P = 0.57), and surgical site occurrences requiring procedural intervention (3% vs. 6%, P = 0.13). Finally, long-term recurrence rates were similar (12% vs. 12%, P = 1). CONCLUSION: Non-opioid postoperative regimens for analgesia are non-inferior to opioids in VHR patients with similar outcomes. Aggressive efforts should be undertaken to reduce opioid use in this population.

Does a "hernia center" label provide better 30-day outcomes following elective ventral hernia repair?: An analysis of the ACHQC database.

INTRODUCTION: Currently, there is no agreed upon definition of a designated hernia center (DHC) and no study has investigated the association of hernia center designation with ventral hernia repair (VHR) outcomes. We sought to investigate the current utilization of DHC and the association of hernia center designation with VHR outcomes. METHODS: All patients who underwent elective, ventral hernia repair with mesh with 30-day follow-up from 2013 through 2020 were in the Americas Hernia Society Quality Collaborative (ACHQC) database. Patients were divided into two groups: those that underwent VHR at a DHC and those that underwent VHR at a non-designated hernia center site (NDHC). Using a 1:1 matched analysis, differences in the incidence of 30-day wound events, the total number of 30-day complications, one-year ventral hernia recurrence rates, and 30-day and one-year patient reported outcomes were compared between DHC and NDHC. RESULTS: A total of 261 sites were included in our analysis; 78 (30%) were identified as DHC. After matching, there were 14,186 VHRs available for analysis. There was no significant difference in 30-day wound morbidity events. Patients who underwent VHR at NDHC were less likely to experience any 30-day complication or 1-year hernia recurrence while patients who underwent VHR at DHC had a statistically significant greater improvement in their HerQLes scores at one-year postoperatively. CONCLUSIONS: There is currently no clear superiority to VHR at a DHC. The ACHQC may self-select for surgeons invested in hernia repair outcomes regardless of hernia center designation. More standardized criteria for a hernia center are required in order to positively influence the value of hernia care delivered in the United States.

Open preperitoneal inguinal hernia repair has superior 1-year patient-reported outcomes compared to Shouldice non-mesh repair.

INTRODUCTION: The Shouldice method for inguinal hernia repair remains the gold standard for prosthesis-free repairs. Nonetheless, international guidelines have favored posterior mesh reinforcement as the standard of care for inguinal hernia repair due to lower risk of recurrence and chronic pain, avoidance of general anesthesia, and favorable biomechanical properties. Recent publications have shown the benefits of an open approach to posterior repairs. Herein, we use the Abdominal Core Health Quality Collaborative (ACHQC) registry to compare patient-reported outcomes after a Shouldice no-mesh repair versus open preperitoneal (OPP) mesh repair. METHODS: We performed a propensity score matched analysis to compare patient-reported quality of life (QoL) and peri/postoperative outcomes after a Shouldice repair versus OPP. Data from 2012 to 2022 were obtained from the ACHQC, and 1:1 optimal matching was performed. EuraHS scores were used to estimate QoL, and further analysis on the EuraHS domains of pain, aesthetics, and activity restriction were performed between the two cohorts. RESULTS: Matching resulted in 257 participants in each, Shouldice and OPP cohorts. OPP was associated with a better QoL score compared to Shouldice at 30 days after surgery (Median (IQR) 7.75 (2.0-17.0) vs 13.0 (4.0-26.1); OR 0.559 [0.37, 0.84]; p = 0.003). This difference persisted at 6 months and 1 year postoperatively (OR 0.447 [0.26, 0.75] and 0.492 [0.26, 0.93], respectively). We did not observe any significant differences in hernia recurrence risk at 1-year, or rates of 30-day SSOs/SSIs, postoperative bleeding, peripheral nerve injury, DVTs, or UTIs. CONCLUSION: Our data suggest that OPP is associated with significantly better patient-reported QoL, in the first month after surgery and up to 1 year postoperatively, especially with respect to lesser pain, when compared to the Shouldice repair. In specialized inguinal hernia practices, open posterior mesh repairs may lead to better outcomes than non-mesh repairs. We encourage more training in both repairs to facilitate larger prospective studies and evaluation of the generalizability of these results to all surgeons performing IHR.

What would you do (WWYD)? Thinking outside the virtual lecture box during COVID-19 and beyond.

Background: The COVID-19 pandemic disrupted many aspects of personal and professional life for surgeons, with resulting suspension of many in-person educational opportunities in favor of virtual education programs. Adapting to these new challenges, we developed, implemented, and evaluated a novel approach to Department of Surgery Grand Rounds to meet the educational needs of residents. Methods: At the outset of COVID-19-related restrictions, educational leadership performed a needs assessment of resident education, leading to a quick pivot to video-based programming. We developed "What Would You Do?" (WWYD), a virtual case-based educational session. Junior residents worked with senior residents, fellows, and faculty to develop disease-specific cases and questions, which were then presented to a panel of invited national subject experts. Feedback was collected from attendees after each grand rounds session via electronic survey, and the panel logistics and "flipped classroom" style of questioning iteratively adapted based on survey responses, verbal feedback, and educational principles. A department-wide survey was conducted at the end of the first year of virtual sessions to assess faculty and trainee perceptions of virtual vs. in-person didactics. Results: While COVID-19 educational materials were widely available, needs assessment found that surgical educational programming for trainees was dramatically reduced. Over a period of 24 months, we hosted twelve WWYD sessions with 20 internal faculty and 22 national virtual guest panelists. WWYD covered core surgical topics, such as hernia, colorectal, trauma, endocrine, vascular, foregut, and transplant. Weekly attendance ranged from 40 to 100, including faculty, trainees, and students. Attendees at WWYD grand rounds reported more strong agreement that speakers communicated effectively (93.7% vs. 79.8%, p < 0.0001), and that topics were engaging (92.4% vs. 78.5%, p < 0.0001) and relevant (91.5% vs. 79.7%, p < 0.0001), when compared to didactic virtual grand rounds. Department-wide survey noted differences in faculty vs. trainee priorities for didactic sessions, with faculty both finding virtual didactics more convenient (92.1% vs. 71.4% strong agreement, p = 0.004) and more highly valuing convenience (89.7% vs. 69.1% highly value, p = 0.005). Conclusions: During an isolating time, the WWYD format leveraged affordances of a virtual platform to bring diverse content experts together for disease-specific discussions, aligning with problem-based, active learning pedagogical approaches which have proven more effective than lectures. Attendees found the format more engaging than virtual didactic lectures, but department-wide survey revealed a dichotomy of didactic priorities between faculty and trainees, with faculty more strongly favoring attendance convenience. WWYD is well-positioned to deliver a didactic educational experience with both engagement and convenience.

Early wound morbidity and clinical outcomes associated with P4HB mesh compared to permanent synthetic mesh in umbilical and small to medium, routine ventral hernia repairs.

Background: Permanent synthetic meshes such as polypropylene (PP) have been utilized for hernia repair for decades, but concerns remain regarding potential long-term, mesh-related complications. A resorbable polymer such as poly-4-hydroxybutyrate (P4HB) represents an alternative with high initial strength, that gradually resorbs, leaving an abdominal wall that is at least as strong as it would be in its native state. We aimed to compare early wound morbidity and clinical outcomes associated with P4HB to traditional, permanent PP in umbilical and small to medium, routine ventral hernias using data from the Abdominal Core Health Quality Collaborative (ACHQC). Methods: Inclusion criteria for the umbilical cohort included: all Centers for Disease Control and Prevention (CDC) wound classes, all Ventral Hernia Working Group (VHWG) hernia grades, and hernia defects <3 cm. The small to medium, routine ventral hernia cohort was limited to CDC class I wounds, VHWG hernia grades I and II, and hernia defects <5 cm. The study group was comprised of P4HB meshes; the comparator group was an aggregate of PP meshes. Clinical outcomes were assessed at 30 days. Results: There was no significant difference in early wound morbidity, readmission, or reoperation between the P4HB and PP cohorts. A small number of patients experienced SSO, with ≤4% requiring procedural intervention. None of the patients (0% in all cases) experienced skin/soft tissue necrosis, infected seroma, infected hematoma, exposed/contaminated/infected mesh, enterocutaneous fistula, graft failure, or pain requiring intervention at 30-days. However, P4HB was associated with significantly greater operative time, length of stay, and use of myofascial release compared to PP (p < 0.05 in all cases). Conclusions: Short-term clinical outcomes associated with resorbable P4HB mesh are comparable to permanent synthetic PP mesh in umbilical and small to medium, routine ventral hernia repairs, despite significant differences in operative time and length of stay. Longer-term follow-up is needed to expand on the clinical relevance of these short-term findings.

Improved patient-reported outcomes after open preperitoneal inguinal hernia repair compared to anterior Lichtenstein repair: 10-year ACHQC analysis.

INTRODUCTION: The Lichtenstein repair has been synonymous with "open" inguinal hernia repair (IHR) for 40 years. However, international guidelines have suggested that posterior mesh placement results in advantageous biomechanics and reduced risk of nerve-related chronic pain. Additionally, the use of local anesthetics has been shown to reduce postoperative pain and complication risks. An open transrectus preperitoneal/open preperitoneal (TREPP/OPP) repair combines posterior mesh placement with the use of local anesthetic and as such could be the ideal repair for primary inguinal hernia. Using the Abdominal Core Health Quality Collaborative (ACHQC) registry, we compared open anterior mesh with open posterior mesh repairs. METHODS: We performed a propensity score matched analysis of patients undergoing open IHR between 2012 and 2022 in the ACHQC. After 1:1 optimal matching, both the TREPP/OPP and Lichtenstein cohorts were balanced with 451 participants in each group. Outcomes included patient-reported quality of life (QoL), hernia recurrence, and postoperative opioid use. RESULTS: Improvement was seen after TREPP/OPP in EuraHS QoL score at 30 days (OR 0.558 [0.408, 0.761]; p = 0.001), and the difference persisted at 1 year (OR 0.588 [0.346, 0.994]; p = 0.047). Patient-reported opioid use at 30-day follow-up was significantly lower in the TREPP/OPP cohort (OR 0.31 [0.20, 0.48]; p < 0.001). 30-day frequency of surgical-site occurrences was significantly higher in the Lichtenstein repair cohort (OR 0.22 [0.06-0.61]; p = 0.007). There were no statistically significant differences in hernia recurrence risk at 1 year, or rates of postoperative bleeding, peripheral nerve injury, DVTs, or UTIs. CONCLUSION: Our analysis demonstrates a benefit of posterior mesh placement (TREPP/OPP) over anterior mesh placement (Lichtenstein) in open inguinal hernia repair in patient-reported QoL and reduced opioid use.

ABVENTURE-P pilot trial of physical therapy versus standard of care following ventral hernia repair: Protocol for a randomized controlled trial.

Hernia disease is one of the most common reasons patients seek surgical treatment, yet nearly 1 in 4 patients seeking ventral hernia repair in the United States suffer from chronic pain, disability, and diminished physical activity. The relationships between the anterior abdominal wall, lower back, diaphragm, and pelvic floor are critical in providing function and quality of life, yet management of hernia disease has been limited to surgical restoration of anatomy without taking into consideration the functional relationships of the abdominal core. Therefore, the primary goal of this study is to evaluate the feasibility of implementing physical therapy targeted to improving stability and function in this population. A secondary goal is to estimate whether pre-operative abdominal core function predicts responsiveness to physical therapy. This study is a registry-based randomized controlled trial (NCT05142618: Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair (ABVENTURE-P)). All participants will be randomized to one of two post-operative treatment arms: standard of care plus up to 16 sessions of physical therapy, or standard of care alone. Primary timepoints include pre-operative (baseline) and ten weeks after surgery, with intermediate or secondary timepoints 30 days, 6 months, and 1 year post-operative. At each timepoint, participants will undergo functional and patient-reported outcome testing. We will also collect data on retention rate and treatment adherence. An intention to treat approach is planned for all analyses, using all participants who were randomized and have available data at the 10-week timepoint. This is a pilot and feasibility trial, hence our goals are to establish safety and initial efficacy of the PT intervention, retention and adherence to both PT and control arms, whether pre-operative abdominal core function predicts responsiveness to PT, and to collect a large enough sample to power a future definitive multi-center randomized controlled trial.

Robotic vs. Open Approach for Older Adults Undergoing Retromuscular Ventral Hernia Repair.

OBJECTIVE: To describe 30-day outcomes including post-operative complications, readmissions, and quality of life score changes for older adults undergoing elective ventral hernia repair with retromuscular mesh placement and to compare rates of these outcomes for individuals undergoing robotic versus open approaches. SUMMARY OF BACKGROUND DATA: Over one third of patients presenting for elective ventral hernia repair are over the age of 65 and many have complex surgical histories that warrant intricate hernia repairs. Robotic ventral hernia repairs have gained increasing popularity in the US and in some studies have demonstrated decreased rates of postoperative complications, and less pain resulting in shorter hospital stays. However, the robotic approach has several downsides including prolonged operative times as well as the use of pneumo-peritoneum which may be risky in older patients. METHODS: We performed a retrospective review of prospectively collected data in a national hernia specific registry (the Abdominal Core Health Quality Collaborative) and identified patients over the age of 65 undergoing either an open or robotic retromuscular ventral hernia repair. After propensity score matching adjusting for demographic, clinical, and hernia related factors, logistic regression was used to compare 30-day complications, readmission, and quality of life (QoL) scores as captured by the HerQLes scale for patients undergoing each approach. RESULTS: Of 2128 patients who met inclusion criteria, 1695 (79.7%) underwent open ventral hernia repair while 433 (20.3%) underwent robotic repair. After propensity score matching, there were 350 robotic cases and 759 open cases for analysis. Patients undergoing robotic repairs demonstrated significantly shorter length of stays (1 vs 4 days, P < 0.01) and had equivalent odds of both 30-day post-operative complications (odds ratio [OR] 1.15 95% confidence interval 0.92-1.44) and readmission (OR 1.09 95% confidence interval 0.74-1.6) compared to the open approach. QoL scores were similar between groups at 30 days but were slightly better for robotic patients at 1 year (92 vs 84 P < 0.01). CONCLUSIONS: Robotic ventral hernia repair is an option for appropriately selected older patients undergoing retromuscular ventral hernia repair, demonstrating shorter hospital stays and equivalent rates of complications and readmissions in the post-operative period. However, more data is needed regarding QoL outcomes and long-term function, especially as it relates to recurrence rates, between the two approaches.

Ten-year outcomes following ventral hernia repair: making the case for better post-market surveillance in the USA.

BACKGROUND: We sought to identify the 10-year complication and recurrence rates and associated sociodemographic and operative characteristics associated with non-mesh versus mesh-based ventral hernia repairs (VHRs). METHODS: This was an IRB-approved (2020H0317) retrospective longitudinal study of patients undergoing mesh or non-mesh VHR from 2009-2019 at a single tertiary-care institution. The electronic medical record was used to collect sociodemographic, clinical, and intraoperative details, and early (≤ 30 days) and long-term (> 30-day) postoperative complications. Up to ten-year follow-up was obtained for long-term complications, categorized as: hernia recurrence reoperation (HRR), major complications requiring emergency surgery (MCES) (defined as non-elective operations related to the abdominal wall), and non-recurrence procedural intervention (NRPI) (defined as any procedures related to the abdominal wall, bowel, or mesh). Kaplan-Meier survival curves were obtained for each long-term complication. RESULTS: Of the 645 patients identified, the mean age at index operation was 52.51 ± 13.57 years with 50.70% female. Of the index operations, 21.24% were for a recurrence. Procedure categories included: 57.36% incisional, 37.21% non-incisional umbilical, 8.22% non-incisional epigastric, 3.88% parastomal, 0.93% diastasis recti, and 0.47% Spigelian hernias. Operative approaches included open (n = 383), laparoscopic (n = 267), and robotic (n = 21). Fascial closure (81.55%) and mesh use (66.2%) were performed in the majority of cases. Median follow-up time was 2098 days (interquartile range 1320-2806). The rate of short-term complications was 4.81% for surgical site infections, 15.04% for surgical site occurrences, and 13.64% for other complications. At 10 years, the HRR-free survival probability was 85.26%, MCES-free survival probability was 94.44%, and NRPI-free survival probability was 78.11%. CONCLUSIONS: A high proportion of patients experienced long-term recurrence and complications requiring intervention after index VHR. For many patients, a ventral hernia develops into a chronic medical condition. Improved efforts at post-market surveillance of operative approaches and mesh location and type should be undertaken to help optimize outcomes.

Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks.

Objectives: Generating and using real-world evidence (RWE) is a pragmatic solution for evaluating health technologies. RWE is recognized by regulators, health technology assessors, clinicians, and manufacturers as a valid source of information to support their decision-making. Well-designed registries can provide RWE and become more powerful when linked with electronic health records and administrative databases in coordinated registry networks (CRNs). Our objective was to create a framework of maturity of CRNs and registries, so guiding their development and the prioritization of funding. Design setting and participants: We invited 52 stakeholders from diverse backgrounds including patient advocacy groups, academic, clinical, industry and regulatory experts to participate on a Delphi survey. Of those invited, 42 participated in the survey to provide feedback on the maturity framework for CRNs and registries. An expert panel reviewed the responses to refine the framework until the target consensus of 80% was reached. Two rounds of the Delphi were distributed via Qualtrics online platform from July to August 2020 and from October to November 2020. Main outcome measures: Consensus on the maturity framework for CRNs and registries consisted of seven domains (unique device identification, efficient data collection, data quality, product life cycle approach, governance and sustainability, quality improvement, and patient-reported outcomes), each presented with five levels of maturity. Results: Of 52 invited experts, 41 (79.9%) responded to round 1; all 41 responded to round 2; and consensus was reached for most domains. The expert panel resolved the disagreements and final consensus estimates ranged from 80.5% to 92.7% for seven domains. Conclusions: We have developed a robust framework to assess the maturity of any CRN (or registry) to provide reliable RWE. This framework will promote harmonization of approaches to RWE generation across different disciplines and health systems. The domains and their levels may evolve over time as new solutions become available.

Long-Term, Prospective, Multicenter Study of Poly-4-Hydroxybutyrate Mesh (Phasix Mesh) for Hernia Repair in Cohort at Risk for Complication: 60-Month Follow-Up.

BACKGROUND: Long-term resorbable mesh represents a promising technology for ventral and incisional hernia repair (VIHR). This study evaluates poly-4-hydroxybutyrate mesh (P4HB; Phasix Mesh) among comorbid patients with CDC class I wounds. STUDY DESIGN: This prospective, multi-institutional study evaluated P4HB VIHR in comorbid patients with CDC class I wounds. Primary outcomes included hernia recurrence and surgical site infection. Secondary outcomes included pain, device-related adverse events, quality of life, reoperation, procedure time, and length of stay. Evaluations were scheduled at 1, 3, 6, 12, 18, 24, 30, 36, and 60 months. A time-to-event analysis (Kaplan-Meier) was performed for primary outcomes; secondary outcomes were reported as descriptive statistics. RESULTS: A total of 121 patients (46 male, 75 female) 54.7 ± 12.0 years old with a BMI of 32.2 ± 4.5 kg/m 2 underwent VIHR with P4HB Mesh (mean ± SD). Fifty-four patients (44.6%) completed the 60-month follow-up. Primary outcomes (Kaplan-Meier estimates at 60 months) included recurrence (22.0 ± 4.5%; 95% CI 11.7% to 29.4%) and surgical site infection (10.1 ± 2.8%; 95% CI 3.3 to 14.0). Secondary outcomes included seroma requiring intervention (n = 9), procedure time (167.9 ± 82.5 minutes), length of stay (5.3 ± 5.3 days), reoperation (18 of 121, 14.9%), visual analogue scale-pain (change from baseline -3.16 ± 3.35 cm at 60 months; n = 52), and Carolinas Comfort Total Score (change from baseline -24.3 ± 21.4 at 60 months; n = 52). CONCLUSIONS: Five-year outcomes after VIHR with P4HB mesh were associated with infrequent complications and durable hernia repair outcomes. This study provides a framework for anticipated long-term hernia repair outcomes when using P4HB mesh.

Round Ligament Management in Female Patients Undergoing Inguinal Hernia Repair: Should We Divide or Preserve?

BACKGROUND: Although inguinal hernia repair in female patients is less common than in male patients, it remains a frequent procedure. The decision to divide or preserve the round ligament has largely been left to surgeon preference, but little data exists about its impact on outcomes. This study aimed to describe current practices for round ligament management and identify the impact of division on surgical and patient-reported outcomes. STUDY DESIGN: The 2013 to 2021 Abdominal Core Health Quality Collaborative database was queried for all female patients undergoing inguinal hernia repair with 30-day patient-reported outcome data available. Comparison groups were created based on round ligament management: round ligament division (RLD) or round ligament preservation (RLP). RESULTS: We identified 1365 female patients who underwent open (36.3%), laparoscopic (34.5%), or robotic (28.2%) repair. Most were non-recurrent (93%) and unilateral (82.6%). The round ligament was divided in 868 (63.6%) and preserved in 497 (36.4%) cases. There were no significant differences in overall complications (RLD 7.1%, RLP 5.2%, p = 0.17), reoperation (RLD 0.5%, RLP 0.2%, p = 0.4), or recurrence (RLD 0.1%, RLP 0.4%, p = 0.28). Mean European Registry for Abdominal Wall Hernias quality of life summary scores were not significantly different at 30 days (RLD 27.2, RLP 27.8) or 6 months (RLD 12.8, RLP 17.1). However, a significant difference was found in terms of mean pain-specific scores at 6 months, with lower pain scores in the RLD group (3 vs 4.7, p < 0.01), which persisted on multivariable analysis (p = 0.02). CONCLUSIONS: RLD is a common practice and is not associated with increased complications or recurrence. Although there is some evidence that RLD may result in decreased pain at 6 months, this must be balanced with potential functional complications of division that are not fully studied in this paper.

Impact of insurance type in postoperative emergency department utilization and clinical outcomes following ventral hernia repair (VHR).

BACKGROUND: Access to care and barriers to achieving health equity remain persistent and prevailing issues in the USA, particularly for low socioeconomic (L-SES) populations. Previous studies have shown that public insurance (a surrogate marker for L-SES) is an independent predictor of emergent hernia repair. However, the impact of insurance type on postoperative healthcare utilization, including emergency department (ED) care, following ventral hernia repair (VHR) remains unknown. METHODS: The 2013-2020 Abdominal Core Health Quality Collaborative (ACHQC) database was used to identify patients aged 18-64 undergoing ventral hernia repair (VHR) who had private or Medicaid insurance. Patients with no health insurance were also included. Using insurance type, the cohort was divided into three groups: private, public (Medicaid), and uninsured (self-pay). Multivariate logistic regression analyses were used to assess the impact of insurance type on emergency department (ED) utilization, postoperative complications, and readmission. RESULTS: A total of 17,036 patients undergoing VHR were included in the study, out of which 13,980 (85.8%) had private insurance, 2,451 (8.4%) had public, and 605 (5.8%) were uninsured. Following adjustment for demographics (age, gender, race), comorbidities (hypertension, diabetes, smoking), and clinical characteristics (emergent procedure, ASA class, surgical approach), public insurance was associated with 1.7 times greater odds of returning to the emergency department (ED) within 30 days of surgery compared to private insurance (95% CI 1.4, 2.0; p = 0.01). Public insurance or being uninsured was also associated with increased odds of experiencing any postoperative complications compared to those who were privately insured (public: OR 1.3, p < 0.01; self-pay: OR 1.67, p < 0.01). CONCLUSION: Our study demonstrates that public and self-pay insurance are associated with increased emergency department (ED) utilization and worse postoperative outcomes compared to those with private insurance. In an effort to promote health equity, healthcare providers need to assess how parameters beyond physical presentation may impact a patient's health.

Virtual Interviews for Surgical Fellowship are an Acceptable Alternative to In-Person Interviews for Applicants and Faculty Alike.

Background: In-person interviews have traditionally been an integral part of the fellowship application process to allow faculty and applicants to interact and evaluate the intangible aspects of the matching process. COVID-19 has forced a transition away from in-person interviews to a virtual platform. This study sought to track faculty and applicant perspectives on this transition. Study Design: Prospectively collected survey data was obtained from all participants after each of 3 consecutive virtual interview days for minimally invasive surgery fellowship at a single academic institution. Results: One hundred percent (27/27 applicants and 9/9 faculty) of interview participants completed the survey. Cost (100% applicants, 77.8% faculty) was perceived as the greatest barrier to in-person interviews, and "inability to get a feel for the program/applicant" was the largest concern for virtual interviews (66.7% applicants, 88.9% faculty). After interviews, most participants strongly agreed that they were able to assess education (66.7% applicants, 77.8% faculty), clinical experience (70.4% applicants, 77.8% faculty), and research potential (70.4% applicants, 88.9% faculty) through the virtual platform. Only 44.4% of each group strongly agreed that they could assess "overall fit" equally as well. Most faculty (6/9, 66.7%), but fewer applicants (10/27, 37.0%), were willing to completely eliminate in-person interviews. Conclusion: Virtual interviews may be an acceptable alternative to in-person interviews in times of COVID-19 and beyond. Offering a virtual format may help to eliminate costs associated with in-person visits while adequately assessing the fit of a program for both applicants and faculty, though applicants still desire an in-person option.