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.

Prospective, multicenter study of P4HB (Phasix™) mesh for hernia repair in cohort at risk for complications: 3-Year follow-up.

BACKGROUND: This study represents a prospective, multicenter, open-label study to assess the safety, performance, and outcomes of poly-4-hydroxybutyrate (P4HB, Phasix™) mesh for primary ventral, primary incisional, or multiply-recurrent hernia in subjects at risk for complications. This study reports 3-year clinical outcomes. MATERIALS AND METHODS: P4HB mesh was implanted in 121 patients via retrorectus or onlay technique. Physical exam and/or quality of life surveys were completed at 1, 3, 6,12, 18, 24, and 36 months, with 5-year (60-month) follow-up ongoing. RESULTS: A total of n = 121 patients were implanted with P4HB mesh (n = 75 (62%) female) with a mean age of 54.7 ± 12.0 years and mean BMI of 32.2 ± 4.5 kg/m2 (±standard deviation). Comorbidities included: obesity (78.5%), active smokers (23.1%), COPD (28.1%), diabetes mellitus (33.1%), immunosuppression (8.3%), coronary artery disease (21.5%), chronic corticosteroid use (5.0%), hypo-albuminemia (2.5%), advanced age (5.0%), and renal insufficiency (0.8%). Hernias were repaired via retrorectus (n = 45, 37.2% with myofascial release (MR) or n = 43, 35.5% without MR), onlay (n = 8, 6.6% with MR or n = 24, 19.8% without MR), or not reported (n = 1, 0.8%). 82 patients (67.8%) completed 36-month follow-up. 17 patients (17.9% ± 0.4%) experienced hernia recurrence at 3 years, with n = 9 in the retrorectus group and n = 8 in the onlay group. SSI (n = 11) occurred in 9.3% ± 0.03% of patients. CONCLUSIONS: Long-term outcomes following ventral hernia repair with P4HB mesh demonstrate low recurrence rates at 3-year (36-month) postoperative time frame with no patients developing late mesh complications or requiring mesh removal. 5-year (60-month) follow-up is ongoing.

The COVID-19 reset: lessons from the pandemic on Burnout and the Practice of Surgery.

BACKGROUND: Burnout among physicians is an increasing concern, and surgeons are not immune to this threat. The ongoing COVID-19 pandemic has caused dramatic changes to surgeon workflow, often leading to redeployment to other clinical areas, slowdown and shutdown of elective surgery practices, and an uncertain future of surgical practice in the post-pandemic setting. Paradoxically, for many surgeons who had to prepare for but not immediately care for a major surge, the crisis did allow for reflective opportunities and a resetting of priorities that could serve to mitigate chronic patterns contributory to Burnout. METHODS: SAGES Reimagining the Practice of Surgery task force convened a webinar to discuss lessons learned from the COVID pandemic that may address burnout. RESULTS: Burnout is multifactorial and may vary in cause among different generation/experience groups. Those that report burnout symptoms often complain of lacking purpose or meaning in their work. Although many mechanisms to address Burnout are from a defensive standpoint-including coping mechanisms, problem solving, and identification of a physician having wellness difficulties-offensive mechanisms such as pursuing purpose and meaning and finding joy in one's work can serve as reset points that promote thriving and fulfillment. Understanding what motivates physicians will help physician leaders to develop and sustain effective teams. Reinvigorating the surgical workforce around themes of meaning and joy in the service rendered via our surgical skills may diminish Burnout through generative and aspirational strategies, as opposed to merely reactive ones. Fostering an educational environment free of discriminatory or demeaning behavior may produce a new workforce conducive to enhanced and resilient wellbeing at the start of careers. CONCLUSION: Surgeon wellness and self-care must be considered an important factor in the future of all healthcare delivery systems, a need reaffirmed by the COVID-19 pandemic.

Management of a primary ventral incisional hernia: a survey of the International Hernia Collaboration.

A social media group, the International Hernia Collaboration (IHC), facilitates professional development among surgeons interested in hernia disease. The purpose of this study was to assess practice pattern differences among IHC surgeon members regarding a ventral incisional hernia (VIH) scenario. A single multiple-choice question, posted for 1 month on the IHC, assessed which operation was preferred for a healthy patient with a symptomatic, reducible primary VIH (5 × 6 cm). Responses were compared by surgeon practice location (US vs. World). In total, 371 IHC surgeons completed the survey. More respondents practicing in the US completed the survey (57.1% vs. 42.9%, P < 0.01). Respondents in the US cohort would select a robotic-assisted approach more frequently than World colleagues (47.6% vs. 8.8%, P < 0.01). More IHC surgeons in the US cohort would offer a robotic-assisted approach for primary VIH repair compared to World colleagues. Studies are warranted to investigate practice pattern differences related to VIH repair.

A Society of Gastrointestinal and Endoscopic Surgeons (SAGES) statement on closed social media (Facebook®) groups for clinical education and consultation: issues of informed consent, patient privacy, and surgeon protection.

INTRODUCTION: Closed social media groups (CSMG), including closed Facebook® groups, are online communities providing physicians with platforms to collaborate privately via text, images, videos, and live streaming in real time and optimize patient care. CSMG platforms represent a novel paradigm in online learning and education, so it is imperative to ensure that the public and patients trust the physicians using these platforms. Informed consent is an essential aspect of establishing this trust. With the launch of several of its own CSMG, Society of Gastrointestinal and Endoscopic Surgeons (SAGES) sought to define its position on CSMG platforms and provide an informed consent template for educating and protecting patients, surgeons, and institutions. METHODS: A review of the literature (2012-2018) discussing the informed consent process for posting clinical scenarios, photography, and/or videography on social media was performed. Pertinent articles and exemplary legal counsel-approved CSMG policies and informed consent forms were reviewed by members of the SAGES Facebook® Task Force. RESULTS: Eleven articles and two institutional CSMG policies discussing key components of the informed consent process, including patient transparency and confidentiality, provider-patient partnerships, ethics, and education were included. Using this information and expert opinion, a SAGES-approved statement and informed consent template were formulated. CONCLUSIONS: SAGES endorses the professional use of medical and surgical CSMG platforms for education, patient care optimization, and dissemination of clinical information. Despite the growing use of social media as an integral tool for surgical practice and education, issues of informed consent still exist and remain the responsibility of the physician contributor. Responsible, ethical, and compliant use of CSMG platforms is essential. Surgeons and patients embracing CSMG for quality improvement and optimized outcomes should be legally protected. SAGES foresees the use of this type of platform continuing to grow.

Erratum to: First human use of hybrid synthetic/biologic mesh in ventral hernia repair: a multicenter trial.

Some values in the pages 1, 3, and 5 of the original article are corrected and also an updated Table 5 is displayed.

First human use of hybrid synthetic/biologic mesh in ventral hernia repair: a multicenter trial.

BACKGROUND: Mesh options for reinforcement of ventral/incisional hernia (VIH) repair include synthetic or biologic materials. While each material has known advantages and disadvantages, little is understood about outcomes when these materials are used in combination. This multicenter study reports on the first human use of a novel synthetic/biologic hybrid mesh (Zenapro® Hybrid Hernia Repair Device) for VIH repair. METHODS: This prospective, multicenter post-market clinical trial enrolled consecutive adults who underwent elective VIH repair with hybrid mesh placed in the intraperitoneal or retromuscular/preperitoneal position. Patients were classified as Ventral Hernia Working Group (VHWG) grades 1-3 and had clean or clean-contaminated wounds. Outcomes of ventral and incisional hernia were compared using appropriate parametric tests. RESULTS: In all, 63 patients underwent VIH repair with hybrid mesh. Most were females (54.0%), had a mean age of 54.8 ± 10.9 years and mean body mass index of 34.5 ± 7.8 kg/m2, and classified as VHWG grade 2 (87.3%). Most defects were midline (92.1%) with a mean area of 106 ± 155 cm2. Cases were commonly classified as clean (92.1%) and were performed laparoscopically (60.3%). Primary fascial closure was achieved in 82.5% with 28.2% requiring component separation. Mesh location was frequently intraperitoneal (69.8%). Overall, 39% of patients available for follow-up at 12 months suffered surgical site events, which were generally more frequent after incisional hernia repair. Of these, seroma (23.7%) was most common, but few (8.5%) required procedural intervention. Other surgical site events that required procedural intervention included hematoma (1.7%), wound dehiscence (1.7%), and surgical site infection (3.4%). Recurrence rate was 6.8% (95% CI 2.2-16.6%) at 12-months postoperatively. CONCLUSION: Zenapro® Hybrid Hernia Repair Device is safe and effective in VHWG grade 1-2 patients with clean wounds out to 12 months. Short-term outcomes and recurrence rate are acceptable. This hybrid mesh represents a novel option for reinforcement during VIH repair.

Comparative analysis of open and robotic transversus abdominis release for ventral hernia repair.

BACKGROUND: Transversus abdominis release (TAR) is a safe, effective strategy to repair complex ventral incisional hernia (VIH); however, open TAR (o-TAR) often necessitates prolonged hospitalization. Robot-assisted TAR (r-TAR) may benefit short-term outcomes and shorten convalescence. This study compares 90-day outcomes of o-TAR and r-TAR for VIH repair. METHODS: A single-center, retrospective review of patients who underwent o-TAR or r-TAR for VIH from 2015 to 2016 was conducted. Patient and hernia characteristics, operative data, and 90-day outcomes were compared. The primary outcome was hospital length of stay, and secondary metrics were morbidity, surgical site events, and readmission. RESULTS: Overall, 102 patients were identified (76 o-TAR and 26 r-TAR). Patients were comparable regarding age, gender, body mass index, and the presence of co-morbidities. Diabetes was more common in the open group (22.3 vs. 0%, P = 0.01). Most VIH defects were midline (89.5 vs. 83%, P = 0.47) and recurrent (52.6 vs. 58.3%, P = 0.65). Hernia characteristics were similar regarding mean defect size (260 ± 209 vs. 235 ± 107 cm2, P = 0.55), mesh removal, and type/size mesh implanted. Average operative time was longer in the r-TAR cohort (287 ± 121 vs. 365 ± 78 min, P < 0.01) despite most receiving mesh fixation with fibrin sealant alone (18.4 vs. 91.7%, P < 0.01). r-TAR trended toward lower morbidity (39.2 vs. 19.2%, P = 0.09), less severe complications, and similar rates of surgical site events and readmission (6.6 vs. 7.7%, P = 1.00). In addition, r-TAR resulted in a significantly shorter median hospital length of stay compared to o-TAR (6 days, 95% CI 5.9-8.3 vs. 3 days, 95% CI 3.2-4.3). CONCLUSIONS: In select patients, the robotic surgical platform facilitates a safe, minimally invasive approach to complex abdominal wall reconstruction, specifically TAR. Robot-assisted TAR for VIH offers the short-term benefits of low morbidity and decreased hospital length of stay compared to open TAR.

Prospective evaluation of poly-4-hydroxybutyrate mesh in CDC class I/high-risk ventral and incisional hernia repair: 18-month follow-up.

BACKGROUND: Long-term resorbable mesh represents a promising technology for complex ventral and incisional hernia repair (VIHR). Preclinical studies indicate that poly-4-hydroxybutyrate (P4HB) resorbable mesh supports strength restoration of the abdominal wall. This study evaluated outcomes of high-risk subjects undergoing VIHR with P4HB mesh. METHODS: This was a prospective, multi-institutional study of subjects undergoing retrorectus or onlay VIHR. Inclusion criteria were CDC Class I, defect 10-350 cm2, ≤ 3 prior repairs, and ≥ 1 high-risk criteria (obesity (BMI: 30-40 kg/m2), active smoker, COPD, diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, hypoalbuminemia, advanced age, and renal insufficiency). Physical exam and/or quality of life surveys were performed at regular intervals through 18 months (to date) with longer-term, 36-month follow-up ongoing. RESULTS: One hundred and twenty-one subjects (46M, 75F) with an age of 54.7 ± 12.0 years and BMI of 32.2 ± 4.5 kg/m2 (mean ± SD), underwent VIHR. Comorbidities included the following: obesity (n = 95, 78.5%), hypertension (n = 72, 59.5%), cardiovascular disease (n = 42, 34.7%), diabetes (n = 40, 33.1%), COPD (n = 34, 28.1%), malignancy (n = 30, 24.8%), active smoker (n = 28, 23.1%), immunosuppression (n = 10, 8.3%), chronic corticosteroid use (n = 6, 5.0%), advanced age (n = 6, 5.0%), hypoalbuminemia (n = 3, 2.5%), and renal insufficiency (n = 1, 0.8%). Hernia types included the following: primary ventral (n = 17, 14%), primary incisional (n = 54, 45%), recurrent ventral (n = 15, 12%), and recurrent incisional hernia (n = 35, 29%). Defect and mesh size were 115.7 ± 80.6 and 580.9 ± 216.1 cm2 (mean ± SD), respectively. Repair types included the following: retrorectus (n = 43, 36%), retrorectus with additional myofascial release (n = 45, 37%), onlay (n = 24, 20%), and onlay with additional myofascial release (n = 8, 7%). 95 (79%) subjects completed 18-month follow-up to date. Postoperative wound infection, seroma requiring intervention, and hernia recurrence occurred in 11 (9%), 7 (6%), and 11 (9%) subjects, respectively. CONCLUSIONS: High-risk VIHR with P4HB mesh demonstrated positive outcomes and low incidence of hernia recurrence at 18 months. Longer-term 36-month follow-up is ongoing.

Weight Loss Failure and Reoperation After Laparoscopic Adjustable Gastric Banding and Gastric Bypass: a Case-Matched Cohort Study.

INTRODUCTION: Not long ago, laparoscopic adjustable gastric banding (LAGB) was considered a safe and effective treatment of morbid obesity; however, long-term outcomes revealed significant complication and failure rates. We hypothesized that LAGB has higher rates of weight loss failure, reoperation, and overall failure compared to laparoscopic gastric bypass (LRYGB) at long-term follow-up. METHODS: A matched case-control study was performed. Patients who underwent primary LAGB or LRYGB at a university hospital between 2004 and 2011 were propensity matched for age, gender, race, body mass index (BMI), and weight-related co-morbidities. Outcomes included demographics, percent excess weight loss (% EWL) and reoperation, weight loss failure (<50% EWL), and overall failure (procedure-related reoperation and/or <50% EWL) at 3- and 5-year follow-up. RESULTS: In all, 228 LAGB and 228 LRYGB patients matched. LAGB patients had less mean EWL at 3 years (35 vs. 71%, P < 0.05) and 5 years (29.3 vs. 66.7%, P < 0.05). LAGB (11%) and LRYGB (11.5%) patients required procedure-related reoperation. More LAGB patients suffered weight loss failure at 3 years (75 vs. 10.5%, P < 0.05) and 5 years (81.5 vs. 15.4%, P < 0.05). Overall failure rates were higher after LAGB. The most common complication after LAGB was pouch/esophageal enlargement (9.7%) and after LRYGB was internal hernia (4.8%). LAGB patients had higher morbidity (19 vs. 12.7%, P = 0.04) but similar procedure-related mortality (0 vs. 0.4%). CONCLUSIONS: LAGB has significantly higher rates of weight loss failure compared to LRYGB with similar rates of procedure-related reoperation. Overall failure rates are higher after LAGB. These data suggest the long-term effectiveness of LAGB might be limited.

A national survey of educational resources utilized by the Resident and Associate Society of the American College of Surgeons membership.

BACKGROUND: Contemporary surgical education includes online resources, mobile platform applications, and simulation training. The aim of this study was to characterize educational tools used by surgical residents. METHODS: An anonymous web-based survey was distributed to 9,913 members of the Resident and Associate Society of the American College of Surgeons. RESULTS: We received 773 completed surveys. To prepare for examinations and expand fund of knowledge, most respondents used printed textbooks, online textbooks, and Surgical Council on Resident Education modules, respectively. Respondents used online textbooks and journal articles most often to investigate timely patient care issues. In contrast, mobile platform applications and online videos/lectures were used least. Fewer than half of respondents used simulators, limited by clinical duties, absence of feedback/supervision, and lack of working supplies. CONCLUSIONS: Traditional educational resources dominate trainee preferences, although utilization of the Surgical Council on Resident Education curriculum continues to grow. Simulators remain a required tool for laparoscopic training, and incorporation of structured feedback and improved supervision may improve utilization.

Adrenal myelolipoma: operative indications and outcomes.

BACKGROUND: Adrenal myelolipoma (AM) is a benign lesion for which adrenalectomy is infrequently indicated. We investigated operative indications and outcomes for AM in a large single-institution series. SUBJECTS AND METHODS: A retrospective cohort study of prospectively collected data was conducted. Patients (≥16 years of age) who underwent adrenalectomy in the Division of General Surgery at Barnes-Jewish Hospital (1993-2010) were grouped by operative indication (myelolipoma versus other pathology) and compared using nonparametric tests (α<0.05). RESULTS: Sixteen patients (4.0%) had myelolipomas resected out of 402 patients who underwent adrenalectomy. Fourteen patients with suspected AM underwent adrenalectomy, 13 (93%) of whom had AM confirmed on pathology. Indications for adrenalectomy were abdominal or flank pain, large tumor size (>8 cm), atypical radiologic appearance, and/or inferior vena cava compression. Three patients with suspected other adrenal lesions had AM confirmed on final pathology. Operative approach was laparoscopic in 15 cases and open in 1 case of a 21-cm lesion. Patients who underwent laparoscopic adrenalectomy for AM (n=15) or other adrenal pathology (n=343) were similar with respect to age, gender, American Society of Anesthesiologists classification, prior abdominal operation, tumor side, operative time, conversion rate, estimated blood loss, intraoperative complications, hospital length of stay, and 30-day morbidity. However, patients with resected AM had a higher body mass index (36.5±8.1 kg/m(2) versus 30.1±7.5 kg/m(2); P<.01) and a larger preoperative tumor size (8.4±3.0 cm versus 3.1±1.7 cm; P<.01). CONCLUSIONS: Laparoscopic adrenalectomy may be appropriate for patients with a presumptive diagnosis of AM and abdominal or flank pain, large tumor size, and/or uncertain diagnosis after imaging. Outcomes and morbidity following LA for AM and other adrenal pathology appear comparable.

Risk factors affecting operative approach, conversion, and morbidity for adrenalectomy: a single-institution series of 402 patients.

BACKGROUND: Risk factors for selecting patients for open adrenalectomy (OA) and for conversion are limited in most series. This study aimed to investigate variables that are important in selecting patients for OA, predict risk of conversion from laparoscopic adrenalectomy (LA), and impact 30-day outcomes of OA and LA. METHODS: A retrospective cohort study of prospectively collected data was conducted. Patients (≥ 16 years old) who underwent adrenalectomy in the Division of General Surgery at Barnes-Jewish Hospital (1993-2010) were grouped by operative approach (LA vs. OA) and compared using nonparametric tests and regression analyses (α < 0.05). RESULTS: In total, 402 patients underwent 422 adrenalectomies. Compared to LA patients, those in the OA group were older (p = 0.02), had higher ASA scores (p = 0.04), larger tumor size (p < 0.01), and fewer functioning lesions (p < 0.01). OA patients more often required concurrent procedures (p < 0.01), had a longer operative time (p = 0.04), more intraoperative complications (p = 0.02), higher estimated blood loss (EBL), and larger transfusion requirement. Preoperative factors that predicted selection for OA were higher patient age (p = 0.01), higher ASA score (p = 0.03), larger tumor size (p < 0.01), nonfunctioning lesion (p < 0.01), diagnosis of adrenocortical carcinoma (p < 0.01), and the need for concomitant procedures (p < 0.01). Conversion to open or hand-assisted approach occurred in 6.2 % of LA patients. Preoperative risks for conversion included large tumor size (>8 cm) and need for concomitant procedures (p < 0.01). Multivariate analysis revealed that large indeterminate adrenal mass, adrenocortical carcinoma, tumor size (>6 cm), an open operation, conversion, concomitant procedures, operative time >180 min, and EBL >200 mL were predictors of 30-day morbidity. CONCLUSIONS: Adrenal tumor size and need for concurrent procedures significantly impact the selection of patients for OA, the likelihood of conversion, and perioperative morbidity. These metrics should be considered when assessing operative approach and risks for adrenalectomy.

Evaluation and management of adrenal incidentaloma.

Adrenal incidentaloma is the most common adrenal neoplasm encountered in clinical practice. The timely, accurate, and cost-effective evaluation and management of adrenal lesions found incidentally can be challenging for clinicians. Evaluation begins with biochemical screening and additional imaging. Management strategies vary by patient factors and tumor characteristics. Adrenalectomy is indicated for lesions that are hormonally active, larger than 4-5 cm, symptom-related, and have an imaging appearance that is atypical of a benign lesion.

Giant, metachronous bilateral dorsalis pedis artery true aneurysms.

This report is the first to describe the clinical, radiographic, operative, and pathologic findings associated with large, bilateral dorsalis pedis artery true aneurysms in a single patient. A 61-year-old African American woman complained of difficulty in wearing shoes. She had a moderately firm, nontender, pulsatile mass on the dorsum of her right foot. Computed tomography and angiography confirmed dorsalis pedis artery aneurysm with sufficient collateralization. She underwent resection without reconstruction. Pathologic analysis revealed a true aneurysm (8 × 5.3 × 4.1 cm(3)) containing intralumenal thrombus. Treatment for small symptomatic and large dorsalis pedis artery aneurysms remains resection with or without reconstruction.