Ventral Hernia Reconstruction with GORE ENFORM Biomaterial.

Introduction: Ventral hernia repair (VHR) is one of the most common surgeries performed in the United States. Degradable mesh is the recommended choice for patients presenting with high-risk co-morbidities or increased risk for infection. GORE® ENFORM BiomaterialTM is a biosynthetic degradable mesh that has recently been approved for use in ventral hernia reconstruction with no reports of its clinical outcomes. Methods: This study was a single surgeon case series. Patients were included in the study if they underwent VHR with GORE® ENFORM BiomaterialTM. The decision to use GORE® ENFORM BiomaterialTM was the senior surgeon's decision based on the patient's center for disease control classification. Patient comorbidities, hernia characteristics, postoperative hernia recurrence, and surgical site occurrences (SSOs) were collected at in-patient follow-up appointments and chart review. Patients were asked to complete preoperative and postoperative patient-reported outcomes (PROs) using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity short form 3a and the hernia-specific quality of life (HerQLes) survey. Results: A total of 15 patients were included in this study. The average length of follow-up was 315 days. Postoperatively, 26.7% of patients had an SSO with 4 surgical site infections. Two patients required an operative washout with mesh removal. One patient experienced hernia recurrence. Eight of the 15 patients completed preoperative and postoperative PROs. Conclusion: This is the first clinical study to report the outcomes of ventral hernia repair using ENFORM mesh. These results show that Enform mesh is an option to consider in complex ventral hernia reconstruction.

Introduction: La réparation d'une hernie ventrale (RHV) est l'une des opérations les plus fréquentes aux États-Unis. Le treillis dégradable est le choix recommandé pour les patients ayant des affections connexes à haut risque ou qui sont vulnérables aux infections. Le biomatériau GORE® ENFORM est un treillis biosynthétique dégradable qui a récemment été approuvé pour la reconstruction des hernies ventrales et dont les résultats cliniques n'ont fait l'objet d'aucun rapport. Méthodologie : La présente étude était constituée d'une série de cas réalisée par un seul chirurgien. Les patients étaient inclus dans l'étude s'ils avaient subi une RHV à l'aide de biomatériau GORE® ENFORM. Le chirurgien en chef prenait la décision d'utiliser ce biomatériau d'après la classification du contrôle des maladies au centre du patient. Les chercheurs ont colligé les affections connexes du patient, les caractéristiques de la hernie, les récurrences de hernie postopératoire et les occurrences au foyer de l'opération (OFO) lors des rendez-vous de suivi et de l'examen des dossiers. Les patients ont été invités à préciser leurs résultats préopératoires et postopératoires (RPP) au moyen du formulaire court 3a sur l'intensité de la douleur tiré du système d'information des mesures de résultats déclarés par le patient (PROMIS) et du sondage sur la qualité de vie propre à la hernie (HerQLes). Résultats : Au total, 15 patients ont participé à l'étude et ont été suivis pendant une durée moyenne de 315 jours. Après l'opération, 26,7% des patients ont présenté une OFO ainsi que quatre infections au foyer de l'opération. Deux patients ont eu besoin d'un lessivage opératoire et du retrait du treillis. Un patient a subi une récurrence de la hernie. Huit des 15 patients ont rempli les RDP avant et après l'opération. Conclusion : Il s'agit de la première étude clinique à déclarer les résultats cliniques de la réparation d'une hernie ventrale à l'aide du treillis ENFORM. Ces résultats démontrent que le treillis Enform peut être envisagé pour la reconstruction d'une hernie ventrale complexe.

Advances in Hernia Care State of the Art.

The field of hernia surgery has seen many recent advances and continues to evolve. Care of the hernia patient begins preoperatively by ensuring adequate preparation for surgery with surgeons now having the opportunity to accurately predict risk which can aid with informed consent. Imaging studies can now help surgeons diagnose and plan hernia surgery on an individual level based on hernia characteristics as well as abdominal wall musculature. In the operating room, new technology and surgical techniques have allowed surgeons to become increasingly sophisticated with goals of reducing tension on midline closures, utilizing minimally invasive and robotic techniques, and availability of new and varied mesh prosthetics. While modest improvements in outcomes have been witnessed by these advances, there is still opportunity for improvement which will be realized by continued research, use of registries, and education and training. Hernia prevention strategies focusing on minimally invasive surgery, laparotomy closure, and the use of prophylactic mesh will also help with the burden of incisional hernias. These advances in hernia surgery have led to the new field of Abdominal Core Health which helps represent this evolving and growing new subspecialty of general surgery.

Primary Uncomplicated Ventral Hernia Repair: Guidelines and Practice Patterns for Routine Hernia Repairs.

Surgical repair of primary umbilical and epigastric hernias are among the most common abdominal operations in the world. The hernia defects range from small (<1 cm) to large and complex even in the absence of prior incision or repair. Mesh has generally been shown to decrease recurrence rates, and its use and location of placement should be individualized for each patient. Open, laparoscopic, and robotic approaches provide unique considerations for the technical aspects of primary repair with or without mesh augmentation.

The Trauma Activation Review Committee: Response to Undertriage During a Period of Rapid Growth at a Level II Trauma Center.

Trauma triage criteria are constantly being refined for improved identification of severely injured patients. When errors occur, they should be tracked, and triage criteria adjusted to minimize these events. Two time periods of trauma registry data at a single rural level II trauma center were retrospectively compared to evaluate demographics, injuries, and outcomes to identify triage errors. In 300 activated trauma patients during 2011, overtriage was 23% and undertriage was 3.7%. In 1035 activated trauma patients during 2019, overtriage was 20.5% and undertriage was 2.2%. Mortality decreased over time overall. In 2019, Trauma I patients were older, spent more time on the ventilator, and in the ICU (all P < .001). Trauma II patients were also older, had lower ISS, hospital days, and ventilator days (all P < .001). During rapid growth, evaluation of overtriage and undertriage can provide useful feedback for hospital staff to refine triage choices and improve patient outcomes.

Teaching Small Bite Fascial Closure Technique: Improved Accuracy and Consistency Through Simulation.

Despite evidence that small bite closure is beneficial, it is not well documented how accurately and consistently surgeons employ this technique. We created a felt model to simulate fascial closure and educate residents regarding small bites. This study aims to gauge accuracy and consistency of bite size in fascial closure and assess if utilizing a templated model could improve technique. Two 10 cm incisions were made in different pieces of felt. Residents were instructed to suture the incisions to simulate fascial closure by running the incisions closed with 1 cm and 5 mm bites respectively. The process was repeated with templated pieces of felt marking 1 and 0.5 cm to guide bite size. Residents were timed for each closure. The travel and distance from the midline for each bite was measured and analysis performed. 14 residents participated. Paired T-test compared means and standard deviations of bite size. Taking 5 mm bites took more time. Standard deviation of travel and right sided distance from midline were significantly smaller when a template was utilized. Standard deviation of travel as well as right sided distance was also improved when instructed to take 5 mm bites. This study demonstrates that a small bite technique results more closure and that when residents are instructed to take smaller bites. The adage, "aim small, miss small," holds true in fascial closure and may be one reason why small bites improve hernia rates. This study also suggests that the use of a template improves accuracy and consistency of closure regardless of bite size intention.

Robotic Plication of Rectus Diastasis with Associated Hernias: A Case Series.

INTRODUCTION: Rectus diastases (RD) are caused by a weakening of the abdominal musculature and a widening of the linea alba. Some patients are often erroneously told that they are hernias. Despite the fact that they are not true hernias, they are often associated with true hernias and undergo concomitant repairs. Robotic plication of these diastases has been gaining more widespread use in the past few years, but literature regarding outcomes remains limited. MATERIAL AND METHODS: All patients with RD and concomitant ventral hernia that underwent robotic repair were assessed from 2016 to present. Demographics, perioperative morbidity, and outcomes were reviewed, and descriptive analyses were performed. RESULTS: This series consists of 14 patients with an average age of 50.7 years (range 33-78 years), 64% female, and 86% Caucasian. All patients had associated umbilical or ventral/incisional hernia with an average defect size of 7.1cm2 and average mesh size of 254cm2. Robotic transabdominal pre-peritoneal (RTAPP) repair was performed in 67% of cases and robotic extended total extraperitoneal (ReTEP) repair was performed in 33%. Two patients (17%) required conversion to open repair. Hospital length of stay was 0.7 days. There was no morbidity in these patients. At an average follow-up of 2.6 years (range 54-2122 days), the hernia/diastasis recurrence rate is 7.1%. CONCLUSION: The results of this study suggest that robotic plication with intraperitoneal sublay mesh could be an acceptable surgical approach for RD associated with concomitant ventral hernia repair. Further investigation is required to assess outcomes in a larger group of patients and to determine long-term recurrence and complication rates.

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.

A Multicenter Analysis of the Early Impact of COVID-19 on Junior Resident Operative Case Volume.

INTRODUCTION: Institutions have reported decreases in operative volume due to COVID-19. Junior residents have fewer opportunities for operative experience and COVID-19 further jeopardizes their operative exposure. This study quantifies the impact of the COVID-19 pandemic on resident operative exposure using resident case logs focusing on junior residents and categorizes the response of surgical residency programs to the COVID-19 pandemic. MATERIALS AND METHODS: A retrospective multicenter cohort study was conducted; 276,481 case logs were collected from 407 general surgery residents of 18 participating institutions, spanning 2016-2020. Characteristics of each institution and program changes in response to COVID-19 were collected via surveys. RESULTS: Senior residents performed 117 more cases than junior residents each year (P < 0.001). Prior to the pandemic, senior resident case volume increased each year (38 per year, 95% confidence interval 2.9-74.9) while junior resident case volume remained stagnant (95% confidence interval 13.7-22.0). Early in the COVID-19 pandemic, junior residents reported on average 11% fewer cases when compared to the three prior academic years (P = 0.001). The largest decreases in cases were those with higher resident autonomy (Surgeon Jr, P = 0.03). The greatest impact of COVID-19 on junior resident case volume was in community-based medical centers (246 prepandemic versus 216 during pandemic, P = 0.009) and institutions which reached Stage 3 Program Pandemic Status (P = 0.01). CONCLUSIONS: Residents reported a significant decrease in operative volume during the 2019 academic year, disproportionately impacting junior residents. The long-term consequences of COVID-19 on junior surgical trainee competence and ability to reach cases requirements are yet unknown but are unlikely to be negligible.

Are Surgeons of the Abdominal Core Health Quality Collaborative Following Guidelines in Umbilical and Epigastric Hernia Repair?

BACKGROUND: Umbilical and epigastric hernias are among the top three most common hernia surgeries performed in the USA with varied techniques. The European and Americas Hernia Societies (EAHS) recently published guidelines for repair of umbilical and epigastric hernias. We evaluated how closely the general surgeons of the Abdominal Core Health Quality Collaborative (ACHQC) follow these guidelines and to identify areas for possible improvement. METHOD: Data from patients undergoing elective and emergent umbilical or epigastric hernia repair from 2013 to 2021 were extracted from the ACHQC database. The procedures performed on eligible subjects were compared to those proposed by the EAHS guidelines. Data was reported as a percentage and a cutoff of 70% was selected to determine compliance. RESULTS: Based on these criteria, 11,088 patients were included and most of the recommendations, including appropriate preoperative antibiotic dosing (96.1% umbilical; 97.2% epigastric), permanent mesh selection (umbilical 97.8%; 96.1 epigastric), mesh fixation with suture (83.6% umbilical; 75.5% epigastric), use of mesh for open repair of hernias greater than 1 cm (83.6 umbilical; 85.7 epigastric), and primary defect closure during open (98.6% umbilical; 97.5% epigastric) and laparoscopic (99.6% umbilical; 100% epigastric) repair, were met. DISCUSSION: Surgeons of the ACHQC adhere to most of the published guidelines on umbilical and epigastric hernia repair. Further research is needed to reinforce or modify the existing recommendations. Standardization of surgical approach will facilitate additional research needed to improve procedural efficiency, while reducing negative outcomes and cost.

A Simplified Abdominal Wall Model to Teach Complex Abdominal Wall Reconstruction.

A simplified and functional abdominal wall model is necessary for surgical education. The utility of such a model encompasses medical student, resident, and fellow education. This is especially relevant in the fields of general surgery and plastic surgery. An abdominal wall model helps with a more complete understanding of abdomen access, hernia repair, and complex abdominal wall reconstruction. Although several models have been proposed, they are expensive and limitations exist due to access, costly repairs, maintenance, and part replacements. There is currently no consensus or widely adopted model used in surgical training programs. We present a simplified abdominal wall model that is inexpensive and easily reproducible.

Patient Referrals for Hernia Consultations through the International Hernia Collaboration (IHC) Online Social Media Platform.

Social media platforms are becoming more ubiquitous in surgery with a mission to bring surgeons closer together through education and learning. The purpose of this project is to evaluate the social media posts relating to referral of patients through one of the online social media platforms. The International Hernia Collaboration closed Facebook site was queried with terms relating to referrals and descriptive statistics generated. There were a total of 36 posts relating to surgical referrals between October 2014 and January 2021. Posts were from 32 different surgeons and included 30 different locations throughout the United States. An online social media platform is a viable way to refer patients throughout the United States and abroad. Further study is needed to evaluate the role of social media for surgical referrals and its impact on patient care.

The T-Line® Hernia Mesh, A Novel Mesh Uniquely Designed to Prevent Hernia Recurrence and Occurrence.

Ventral hernia repair (VHR) fixation techniques with current meshes on the market are prone to failure from intra-abdominal pressure spikes due to coughing or lifting, for example. The T-Line® Hernia Mesh (Deep Blue Medical Advances, Durham, North Carolina) is a new mesh with a novel fixation mechanism to enhance anchoring strength addressing hernia occurrence and recurrence. Used similarly to traditional mesh, the new mesh uses incorporated mesh sutures that are 15 times the surface area of sutures for fixation rather than monofilament sutures, providing ~275% stronger anchoring strength. The increased surface area of the mesh extensions decreases tension on the mesh and tissue and increases the strength of the repair overall. There is also the likelihood that anchoring gains strength over time as the extensions undergo bioincorporation. This novel mesh specifically addresses the most common complication of VHR and has the potential to significantly improve outcomes.

A prospective, multicenter trial of a long-term bioabsorbable mesh with Sepra technology in cohort of challenging laparoscopic ventral or incisional hernia repairs (ATLAS trial).

BACKGROUND: This prospective, multicenter, single-arm, open-label study evaluated P4HB-ST mesh in laparoscopic ventral or incisional hernia repair (LVIHR) in patients with Class I (clean) wounds at high risk for Surgical Site Occurrence (SSO). METHODS: Primary endpoint was SSO requiring intervention <45 days. Secondary endpoints included: surgical procedure time, length of stay, SSO >45 days, hernia recurrence, device-related adverse events, reoperation, and Quality of Life at 1, 3, 6, 12, 18, and 24-months. RESULTS: 120 patients (52.5% male), mean age of 55.0 ± 14.9 years, and BMI of 33.2 ± 4.5 kg/m2 received P4HB-ST mesh. Patient-reported comorbid conditions included: obesity (86.7%), active smoker (45.0%), COPD (5.0%), diabetes (16.7%), immunosuppression (2.5%), coronary artery disease (7.5%), chronic corticosteroid use (2.5%), hypoalbuminemia (0.8%), advanced age (10.0%), and renal insufficiency (0.8%). Hernia types were primary ventral (44.2%), primary incisional (37.5%), recurrent ventral (5.8%), and recurrent incisional (12.5%). Patients underwent LVIHR in laparoscopic (55.8%) or robotic-assisted cases (44.2%), mean defect size 15.7 ± 28.3 cm2, mean procedure time 85.9 ± 43.0 min, and mean length of stay 1.0 ± 1.4 days. There were no SSOs requiring intervention beyond 45 days, n = 38 (31.7%) recurrences, n = 22 (18.3%) reoperations, and n = 2 (1.7%) device-related adverse events (excluding recurrence). CONCLUSION: P4HB-ST mesh demonstrated low rates of SSO and device-related complications, with improved quality of life scores, and reoperation rate comparable to other published studies. Recurrence rate was higher than expected at 31.7%. However, when analyzed by hernia defect size, recurrence was disproportionately high in defects ≥7.1 cm2 (43.3%) compared to defects <7.1 cm2 (18.6%). Thus, in LVIHR, P4HB-ST may be better suited for small defects. Caution is warranted when utilizing P4HB-ST in laparoscopic IPOM repair of larger defects until additional studies can further investigate outcomes.

Exploring the Pharmacokinetics of Phenoxymethylpenicillin (Penicillin-V) in Adults: A Healthy Volunteer Study.

This healthy volunteer study aimed to explore phenoxymethylpenicillin (penicillin-V) pharmacokinetics (PK) to support the planning of large dosing studies in adults. Volunteers were dosed with penicillin-V at steady state. Total and unbound penicillin-V serum concentrations were determined, and a base population PK model was fitted to the data.

The praziquantel in preschoolers (PIP) trial: study protocol for a phase II PK/PD-driven randomised controlled trial of praziquantel in children under 4 years of age.

BACKGROUND: Over 200 million individuals worldwide are infected with Schistosoma species, with over half of infections occurring in children. Many children experience first infections early in life and this impacts their growth and development; however praziquantel (PZQ), the drug used worldwide for the treatment of schistosomiasis, only has regulatory approval among adults and children over the age of four, although it is frequently used "off label" in endemic settings. Furthermore, pharmacokinetic/pharmacodynamics (PK/PD) evidence suggests the standard PZQ dose of 40 mg/kg is insufficient in preschool-aged children (PSAC). Our goal is to understand the best approaches to optimising the treatment of PSAC with intestinal schistosomiasis. METHODS: We will conduct a randomised, controlled phase II trial in a Schistosoma mansoni endemic region of Uganda and a Schistosoma japonicum endemic region of the Philippines. Six hundred children, 300 in each setting, aged 12-47 months with Schistosoma infection will be randomised in a 1:1:1:1 ratio to receive either (1) 40 mg/kg PZQ at baseline and placebo at 6 months, (2) 40 mg/kg PZQ at baseline and 40 mg/kg PZQ at 6 months, (3) 80 mg/kg PZQ at baseline and placebo at 6 months, or (4) 80 mg/kg PZQ at baseline and 80 mg/kg PZQ at 6 months. Following baseline treatment, children will be followed up for 12 months. The co-primary outcomes will be cure rate and egg reduction rate at 4 weeks. Secondary outcomes include drug efficacy assessed by novel antigenic endpoints at 4 weeks, actively collected adverse events and toxicity for 12 h post-treatment, morbidity and nutritional outcomes at 6 and 12 months, biomarkers of inflammation and environmental enteropathy and PZQ PK/PD parameters. DISCUSSION: The trial will provide valuable information on the safety and efficacy of the 80 mg/kg PZQ dose in PSAC, and on the impact of six-monthly versus annual treatment, in this vulnerable age group. TRIAL REGISTRATION: ClinicalTrials.gov NCT03640377 . Registered on 21 Aug 2018.

Optimizing antimicrobial use: challenges, advances and opportunities.

An optimal antimicrobial dose provides enough drug to achieve a clinical response while minimizing toxicity and development of drug resistance. There can be considerable variability in pharmacokinetics, for example, owing to comorbidities or other medications, which affects antimicrobial pharmacodynamics and, thus, treatment success. Although current approaches to antimicrobial dose optimization address fixed variability, better methods to monitor and rapidly adjust antimicrobial dosing are required to understand and react to residual variability that occurs within and between individuals. We review current challenges to the wider implementation of antimicrobial dose optimization and highlight novel solutions, including biosensor-based, real-time therapeutic drug monitoring and computer-controlled, closed-loop control systems. Precision antimicrobial dosing promises to improve patient outcome and is important for antimicrobial stewardship and the prevention of antimicrobial resistance.

Evaluation of Absorbable Mesh for Prophylactic Mesh Augmentation in High-Risk Patients.

PURPOSE: Hernia prevention following abdominal surgery has become a subject of growing interest in general surgery. Prophylactic mesh augmentation (PMA) is an emerging technique to prevent incisional hernia in high-risk populations. The aim of this study was to determine the efficacy and safety of PMA using an absorbable mesh. METHODS: A retrospective review was performed on patients who underwent PMA between July 2014 and March 2020. A prophylactic synthetic absorbable mesh (Phasix™; Becton Dickinson, Franklin Lakes, NJ) was placed at the surgeon's discretion according to the indication for the primary operation. The primary outcome was the incisional hernia rate. Secondary outcomes included mesh-related or other complications. RESULTS: Fifty patients underwent PMA following cystectomy with ileal conduit, open aortic surgery, or colostomy creation/takedown. Overall, 10 patients (20%) developed hernia at a median follow-up of 2.2 years. Six of these 10 hernias occurred at incisions where mesh was not placed. There were no documented mesh infections. One mesh (2%) in the AAA group was explanted due to an infected endograft, but there was no evidence of mesh complication. Two patients (4%) developed seroma. Two (4%) patients developed superficial surgical site infections (SSI). There were no documented deep-space SSI. CONCLUSION: PMA is an emerging technique with a low rate of incisional hernia in high-risk patients, such as those undergoing stoma creation or open aortic intervention. The use of an absorbable mesh seems promising, however more and longer-term research is needed.

Population Pharmacokinetics of Piperacillin in Non-Critically Ill Patients with Bacteremia Caused by Enterobacteriaceae.

This study analyzes the pharmacokinetic variability of piperacillin in non-critically ill patients with Enterobacteriaceae bloodstream infections (EBSI) and explores predicted clinical outcomes and piperacillin-related neurotoxicity under different renal conditions. Hospitalized, non-critically ill patients treated with piperacillin-tazobactam for EBSI were included. Four serum samples per patient were collected and analyzed. A population pharmacokinetic model was developed using the Pmetrics package for R. Monte Carlo simulations of various dosage regimens of 4 g piperacillin, administered q8 h or q12 h by short (0.5 h) or long (4 h) infusion, following the different glomerular filtration rate (GFR) categories used to classify chronic kidney disease (Kidney Disease: Improving Global Outcomes, KDIGO) to determine the probability of target attainment (PTA) using a free drug concentrations above the minimal inhibitory concentration (fT > MIC) of 50% for efficacy and targets for piperacillin-associated neurotoxicity. Twenty-seven patients (102 samples) were included. Extended piperacillin infusions reached a PTA > 90% (50%fT > MIC) within the susceptibility range, although a loading dose did not greatly improve the expected outcome. Long infusions reduced the expected toxicity in patients with severe renal impairment. The study supports the use of extended infusions of piperacillin in non-critically ill patients with EBSI. No benefits of a loading dose were expected in our population. Finally, extended infusions may reduce the risk of toxicity in patients with severe renal impairment.