T-line Hernia Mesh Repairs of Large Umbilical Hernias: Technique and Short-term Outcomes.

Background: The T-line hernia mesh is a synthetic, polypropylene mesh specifically designed to prevent anchor point failure by evenly distributing tension through mesh suture extensions. This case series illustrates the first clinical application of the T-line mesh for umbilical hernia repair (UHR). Methods: This study is a retrospective, consecutive cases series of all adult patients presenting to a single surgeon with symptomatic umbilical hernia requiring surgical repair using the T-line hernia mesh. Patient demographics, surgical details, and 30-day postoperative complications were collected. Descriptive statistics were computed in Microsoft Excel (Redmond, Va.). Results: Three patients presented for UHR. All three patients were obese with mean body mass index of 37.5 ±â€…6.6. Two patients were former smokers, and two had presented after hernia recurrence. The average defect size was 80.1 cm2 ± 94.0 cm2. Two patients had UHR with onlay mesh placement, whereas one had a transversus abdominus release followed by retrorectus mesh placement. The average mesh size was 192.3 cm2 ± 82.5 cm2. All three cases were classified as clean. There were no intraoperative complications. No patients experienced 30-day postoperative complications or recurrence. Conclusions: We present a case series of three patients presenting with large, symptomatic umbilical hernias who underwent UHR with T-line hernia mesh reinforcement without short term complications or hernia recurrence at last follow-up.

Development of a prospective biliary dashboard to compare performance and surgical cost.

BACKGROUND: Transparency around surgeon level data may align healthcare delivery with quality care for patients. Biliary surgery includes numerous procedures performed by both general surgeons and subspecialists alike. Cholecystectomy is a common surgical procedure and an optimal cohort to measure quality outcomes within a healthcare system. METHODS: Data were collected for 5084 biliary operations performed by 68 surgeons in 11 surgical divisions in a health system including a tertiary academic hospital, two regional community hospitals, and two ambulatory surgery centers. A privacy protected dashboard was developed to compare surgeon performance and cost between July 2018 and June 2022. A sample cohort of patients ≥ 18 years who underwent cholecystectomy were compared by operative time, cost, and 30-day outcomes. RESULTS: Over 4 years, 4568 cholecystectomy procedures were performed by 57 surgeons. Operations were done by 57 surgeons in four divisions and included 3846 (84.2%) laparoscopic cholecystectomies, 601 (13.2%) laparoscopic cholecystectomies with cholangiogram, and 121 (2.6%) open cholecystectomies. Patients were admitted from the emergency room in 2179 (47.7%) cases while 2389 (52.3%) cases were performed in the ambulatory setting. Individual surgeons were compared to peers for volume, intraoperative data, cost, and outcomes. Cost was lowest at ambulatory surgery centers, yet only 4.2% of elective procedures were performed at these facilities. Prepackaged kits with indocyanine green were more expensive than cholangiograms that used iodinated contrast. The rate of emergency department visits was lowest when cases were performed at ambulatory surgery centers. CONCLUSION: Data generated from clinical dashboards can inform surgeons as to how they compare to peers regarding quality metrics such as cost, time, and complications. In turn, this may guide strategies to standardize care, optimize efficiency, provide cost savings, and improve outcomes for cholecystectomy procedures. Future application of clinical dashboards can assist surgeons and administrators to define value-based care.

Development and Evaluation of a Novel Instrument to Measure Severity of Intraoperative Events Using Video Data.

OBJECTIVE: To develop and evaluate a novel instrument to measure SEVERE processes using video data. BACKGROUND: Surgical video data can serve an important role in understanding the relationship between intraoperative events and postoperative outcomes. However, a standard tool to measure severity of intraoperative events is not yet available. METHODS: Items to be included in the instrument were identified through literature and video reviews. A committee of experts guided item reduction, including pilot tests and revisions, and determined weighted scores. Content validity was evaluated using a validated sensibility questionnaire. Inter-rater reliability was assessed by calculating intraclass correlation coefficient. Construct validity was evaluated on a sample of 120 patients who underwent laparoscopic Roux-en-Y gastric bypass procedure, in which comprehensive video data was obtained. RESULTS: SEVERE index measures severity of 5 event types using ordinal scales. Each intraoperative event is given a weighted score out of 10. Inter-rater reliability was excellent [0.87 (95%-confidence interval, 0.77-0.92)]. In a sample of consecutive 120 patients undergoing gastric bypass procedures, a median of 12 events [interquartile range (IQR) 9-18] occurred per patient and bleeding was the most frequent type (median 10, IQR 7-14). The median SEVERE score per case was 11.3 (IQR 8.3-16.9). In risk-adjusted multivariable regression models, history of previous abdominal surgery (P = 0.02) and body mass index (P = 0.005) were associated with SEVERE scores, demonstrating construct validity evidence. CONCLUSION: The SEVERE index may prove to be a useful instrument in identifying patients with high risk of developing postoperative complications.

The Use of Fluorescence Angiography During Laparoscopic Sleeve Gastrectomy.

BACKGROUND AND OBJECTIVES: A new technology involving indocyanine green (ICG) fluorescence angiography has been introduced to assess tissue perfusion and perform vascular mapping during laparoscopic surgery. The purpose of this study was to describe the use of this technology to identify the variable blood supply patterns to the stomach and gastroesophageal (GE) junction during laparoscopic sleeve gastrectomy (LSG), which may help in preserving the blood supply and preventing ischemia-related leaks. METHODS: Eighty-six patients underwent LSG and were examined intraoperatively with fluorescence angiography at an academic bariatric center from January 2016 to September 2017. Before the construction of the SG, 1 mL ICG was injected intravenously, and near infrared fluorescence imaging technology was used to identify the blood supply of the stomach. Afterward, the LSG was created with attention to preserving the identified blood supply to the GE junction and gastric tube. Finally, 3 mL ICG was injected to ensure that all the pertinent blood vessels were preserved. RESULTS: Eighty-six patients successfully underwent the laparoscopic procedure with no complications. The following patterns of blood supply to the GE junction were found: (1) a right-side-dominant pattern (20%), arising from the left gastric artery; (2) a right-side-accessory pattern (36%), running in the gastrohepatic ligament and comprising either an accessory hepatic artery or an accessory gastric artery; and (3) a left-side accessory pattern arising from tributaries from the left inferior phrenic artery significantly contributing to the right-side blood supply. In addition, in 10% of the cases both right and left accessory patterns were present simultaneously. CONCLUSION: ICG fluorescence angiography allows determination of the major blood supply to the proximal stomach before any dissection during sleeve gastrectomy, so that an effort can be made to avoid unnecessary injury to these vessels during the procedure.

The mechanism of attenuation of epithelial-mesenchymal transition by a phosphodiesterase 5 inhibitor via renal klotho expression.

Phosphodiesterase-5 (PDE-5) inhibitors induces vasodilation in several organs by blocking cyclic GMP (guanosine monophosphate) degradation. However, the existence of alternative mechanism of action in case of an impaired nitric oxide (NO) system remains controversial. Previous studies suggested that decreased NO bioavailability may result in the downregulation of klotho expression, but the relationship between klotho and NO remains obscure. Therefore, we investigated whether a PDE-5 inhibitor could preserve epithelial-mesenchymal transition (EMT) and relationship exists between the NO and renal klotho expression. Ten-week-old SD rats (N = 24, 200 g, male) were divided (N = 6) into four groups, which received: A LSD, L-NAME 1 mg/mL in drinking water, Udenafil 5 mg/kg subcutaneously and both for 4 weeks. Urine nitrate/nitrite, NGAL (Neutrophil gelatinase-associated lipocalin), and cGMP were measured using ELISA. Kidney was subjected to evaluate PCNA (proliferative cell nuclear antigen), α-SMA (smooth muscle cell antigen), E-cadherin, and klotho expression. Urine cGMP decreased after treatment of PDE-5 inhibitor compared with control due to blocking degradation of cGMP (P < .05, control vs Udenafil and L-NAME with Udenafil groups). Urine NGAL increased after treating of L-NAME and attenuated after using PDE-5 inhibitor (P < .05, control vs L-NAME and L-NAME with Udenafil). PCNA, α-SMA, and E-cadherin (EMT markers) increased after L-NAME treatment and normalized after using PDE-5 inhibitor. Klotho expression showed trend to increase in the L-NAME with PDE-5 inhibitor group compared with the L-NAME group, however, eNOS expression did not change after treatment of L-NAME or PDE-5 inhibitor compared with control. PDE-5 inhibitor alleviates EMT in the kidney via klotho modulation independent of the NO system.

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.

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.

Safety and Efficacy of Polymeric Clips for Appendiceal Stump Closure.

BACKGROUND AND OBJECTIVES: Laparoscopic appendectomy remains one of the most common emergency general surgical procedures in the United States. In an era of increasing focus on costs in medical care, we sought to evaluate the use of polymeric clips to secure the appendiceal base during laparoscopic appendectomy. METHODS: We performed a prospective cohort study of patients undergoing laparoscopic appendectomy from April 2013 through September 2014 at a single academic teaching institution. Polymeric clips were used to secure the appendiceal stump. Tissue dissection techniques and control of the mesoappendix were the operating surgeon's choice. Clinical outcomes are reported. RESULTS: A total of 25 patients (56% women; mean age, 41 y; body mass index of 29 kg/m(2)) were enrolled in our study and underwent laparoscopic appendectomy with polymeric clips. One patient was unable to have polymeric clips placed due to inflammation of the appendiceal base. There were no major perioperative complications. One patient developed a suture abscess in the umbilical incision, and another had prolonged ileus with computed tomography demonstrating persistent pelvic fluid that did not require intervention. Median length of stay was 1 d and mean length of follow-up was 81 d. The use of polymeric clips contributed ∼ $32 to the overall operative cost. CONCLUSIONS: Polymeric clips are a safe alternative for securing the appendiceal base in laparoscopic appendectomy. They offer significant cost savings without any evidence of increased complications.

Sorafenib, a multikinase inhibitor, enhances the response of melanoma to regional chemotherapy.

Melanoma responds poorly to standard chemotherapy due to its intrinsic chemoresistance. Multiple genetic and molecular defects, including an activating mutation in the BRaf kinase gene, are associated with melanoma, and the resulting alterations in signal transduction pathways regulating proliferation and apoptosis are thought to contribute to its chemoresistance. Sorafenib, a multikinase inhibitor that targets BRaf kinase, is Food and Drug Administration approved for use in advanced renal cell and hepatocellular carcinomas. Although sorafenib has shown little promise as a single agent in melanoma patients, recent clinical trials suggest that, when combined with chemotherapy, it may have more benefit. We evaluated the ability of sorafenib to augment the cytotoxic effects of melphalan, a regional chemotherapeutic agent, and temozolomide, used in systemic and regional treatment of melanoma, on a panel of 24 human melanoma-derived cell lines and in an animal model of melanoma. Marked differences in response to 10 micromol/L sorafenib alone were observed in vitro across cell lines. Response to sorafenib significantly correlated with extracellular signal-regulated kinase (ERK) downregulation and loss of Mcl-1 expression (P < 0.05). Experiments with the mitogen-activated protein kinase/ERK kinase inhibitor U0126 suggest a unique role for ERK downregulation in the observed effects. Sorafenib in combination with melphalan or temozolomide led to significantly improved responses in vitro (P < 0.05). In the animal model of melanoma, sorafenib in combination with regional melphalan or regional temozolomide was more effective than either treatment alone in slowing tumor growth. These results show that sorafenib in combination with chemotherapy provides a novel approach to enhance chemotherapeutic efficacy in the regional treatment of in-transit melanoma.

Inhibition of poly(ADP-ribose) polymerase enhances the effect of chemotherapy in an animal model of regional therapy for the treatment of advanced extremity malignant melanoma.

BACKGROUND: Poly(ADP-ribose) polymerase (PARP) is an important regulator of programmed cell death in response to alkylating agents such as temozolomide (TMZ). The goal of this study was to determine if a systemically administered PARP-inhibitor (INO-1001) could augment the efficacy of TMZ in a rat model of extremity malignant melanoma. MATERIALS AND METHODS: PARP activity was measured in vitro across a panel of 5 human malignant melanoma-derived cell lines. To evaluate tumor response to PARP inhibition in combination with regional isolated limb infusion (ILI) therapy with TMZ, two TMZ-resistant malignant melanoma cell lines were grown as xenografts in the hind limb of rats. INO-1001 (400 mg/kg) was injected intraperitoneally 7 times every 8 hours prior to ILI. Tumor volume was measured for up to 40 days. RESULTS: In vitro inhibition of PARP activity by INO-1001 ranged from 25.5% to 65.6%. In a mismatch repair (MMR)-deficient xenograft, treatment with INO-1001 prior to ILI significantly (P < .04) increased the efficacy of TMZ. The increase in tumor volume at day 40 following TMZ-ILI with INO-1001 was only 22.6% compared with 322.8% with TMZ-ILI alone. In a xenograft that was MMR-proficient and had high levels of O(6)-methylguanine-DNA methyltransferase (MGMT) activity, there was little improvement in TMZ efficacy with INO-1001 treatment. CONCLUSION: The PARP-inhibitor, INO-1001, can enhance the response of TMZ-resistant, MMR-deficient, malignant melanoma xenografts to intra-arterially administered TMZ in a regional treatment model of advanced extremity malignant melanoma.

Defining regional infusion treatment strategies for extremity melanoma: comparative analysis of melphalan and temozolomide as regional chemotherapeutic agents.

Five different human melanoma xenografts were used in a xenograft model of extremity melanoma to evaluate the variability of tumor response to regionally administered melphalan or temozolomide and to determine if various components of pertinent drug resistance pathways for melphalan [glutathione S-transferase (GST)/glutathione] and temozolomide [O(6)-alkylguanine DNA alkyltranferase (AGT)/mismatch repair (MMR)] could be predictive of tumor response. Xenograft-bearing rats underwent regional isolated limb infusion with either melphalan (90 mg/kg) or temozolomide (2,000 mg/kg). The levels of AGT activity, GST activity, glutathione level, and GST/AGT expression were examined in this group of xenografts and found to be quite heterogeneous. No correlation was identified between melphalan sensitivity and the GST/glutathione cellular detoxification pathway. In contrast, a strong correlation between the levels of AGT activity and percentage increase in tumor volume on day 30 (r = 0.88) was noted for tumors treated with temozolomide. Regional therapy with temozolomide was more effective when compared with melphalan for the xenograft with the lowest AGT activity, whereas melphalan was more effective than temozolomide in another xenograft that had the highest AGT activity. In three other xenografts, there was no significant difference in response between the two chemotherapy agents. This study shows that AGT activity may be useful in predicting the utility of temozolomide-based regional therapy for advanced extremity melanoma tumors. Our observations also point out the limited ability of analysis of the GST/glutathione pathway to predict response to chemotherapies like melphalan whose resistance is primarily mediated through a complex mechanism of detoxification.