Protocol to develop a core outcome set in incisional hernia surgery : the HarMoNY Project

Incisional hernia has an incidence of up to 20% following laparotomy and is associated with significant morbidity and impairment of quality of life. A variety of surgical strategies including techniques and mesh types are available to manage patients with incisional hernia. Previous works have reported significant heterogeneity in outcome reporting for abdominal wall herniae, including ventral and inguinal hernia. This is coupled with under-reporting of important clinical and patient-reported outcomes. The lack of standardisation in outcome reporting contributes to reporting bias, hinders evidence synthesis and adequate data comparison between studies. This project aims to develop a core outcome set (COS) of clinically important, patient-oriented outcomes to be used to guide reporting of future research in incisional hernia. This project has been designed as an international, multicentre, mixed-methods project. Phase I will be a systematic review of current literature to examine the current clinical and patient-reported outcomes for incisional hernia and abdominal wall reconstruction. Phase II will identify the outcomes of importance to all key stakeholders through in depth qualitative interviews. Phase III will achieve consensus on outcomes of most importance and for inclusion into a COS through a Delphi process. Phase IV will achieve consensus on the outcomes that should be included in a final COS. The adoption of this COS into clinical and academic practice will be endorsed by the American, British and European Hernia Societies. Its utilisation in future clinical research will enable appropriate data synthesis and comparison and will enable better clinical interpretation and application of the current evidence base. This study has been registered with the Core Outcome Measures in Effectiveness Trials initiative. CRD42018090084

Multicenter, Prospective, Longitudinal Study of the Recurrence, Surgical Site Infection, and Quality of Life After Contaminated Ventral Hernia Repair Using Biosynthetic Absorbable Mesh: The COBRA Study

OBJECTIVE: The aim of the study was to evaluate biosynthetic absorbable mesh in single-staged contaminated (Centers for Disease Control class II and III) ventral hernia (CVH) repair over 24 months. BACKGROUND: CVH has an increased risk of postoperative infection. CVH repair with synthetic or biologic meshes has reported chronic biomaterial infections and high hernia recurrence rates. METHODS: Patients with a contaminated or clean-contaminated operative field and a hernia defect at least 9 cm had a biosynthetic mesh (open, sublay, retrorectus, or intraperitoneal) repair with fascial closure (n = 104). Endpoints included overall Kaplan-Meier estimates for hernia recurrence and postoperative wound infection rates at 24 months, and the EQ-5D and Short Form 12 Health Survey (SF-12). Analyses were conducted on the intent-to-treat population, and health outcome measures evaluated using paired t tests. RESULTS: Patients had a mean age of 58 years, body mass index of 28 kg/m, 77% had contaminated wounds, and 84% completed 24-months follow-up. Concomitant procedures included fistula takedown (n = 24) or removal of infected previously placed mesh (n = 29). Hernia recurrence rate was 17% (n = 16). At the time of CVH repair, intraperitoneal placement of the biosynthetic mesh significantly increased the risk of recurrences (P ≤ 0.04). Surgical site infections (19/104) led to higher risk of recurrence (P < 0.01). Mean 24-month EQ-5D (index and visual analogue) and SF-12 physical component and mental scores improved from baseline (P < 0.05). CONCLUSIONS: In this prospective longitudinal study, biosynthetic absorbable mesh showed efficacy in terms of long-term recurrence and quality of life for CVH repair patients and offers an alternative to biologic and permanent synthetic meshes in these complex situations

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

Optimizing choledocholithiasis management: a Cost-effectiveness analysis

Hypothesis: Endoscopic retrograde cholangiopancreatography (ERCP) is more cost-effective for managing incidental choledocholithiasis (CDL) after laparoscopic cholecystectomy and intraoperative cholangiogram (LC/IOC) than laparoscopic common bile duct exploration (LCBDE). Design A cost-effectiveness analysis was performed to compare ERCP with LCBDE. Sensitivity analyses were performed to determine the key contributors to cost-effectiveness between the 2 treatment options. Setting Costs were approached from the institutional perspective considering a typical patient undergoing LC/IOC at a large referral center. Patients The base case patient evaluated was a woman 18 years of age or older with symptomatic cholelithiasis and incidental CDL discovered at the time of LC/IOC. Interventions Endoscopic retrograde cholangiopancreatography with drainage procedure performed after LC/IOC or LCBDE during LC/IOC. Main Outcome Measures Costs, quality-adjusted life years gained, mean cost-effectiveness ratios, and incremental cost-effectiveness ratios. Results: In the base case analysis, ERCP was the optimal treatment choice with a cost of $24 300 for 0.9 quality-adjusted life years gained compared with$28 400 and 0.88 quality-adjusted life years for LCBDE. Endoscopic retrograde cholangiopancreatography remained the optimal strategy for CDL in multiway probabilistic sensitivity analysis. If LCBDE were performed and the cost of a potential operative case lost was $3100 or less and the cost of ERCP hospitalization was$18 000 or more, then LCBDE became the preferred treatment for CDL. Conclusions: Endoscopic retrograde cholangiopancreatography was both less costly and more effective than LCBDE. Factors important to choosing the best strategy for CDL management included the cost of a potential case lost due to LCBDE performance and the cost of ERCP hospitalization

Flavour-changing top quark decays in the alternative left-right model

We examine flavour-changing neutral-current decays of the top quark, t→qγ, t→qZ, t→qH, and t→qg (with q=u,c), in the Alternative Left-Right Model, a left right-symmetric model featuring exotic quarks and light bosons. These decays have a very small probability of occurring within the Standard Model, but they can be enhanced in this model through the presence of the exotic states. While associated signals may be detected directly at the LHC, rare decays have the advantage of offering means to probe new particles indirectly, through loop-contributions. We perform a comprehensive analysis of the model's parameter space to demonstrate the possible existence of enhancements in the corresponding branching ratios, of 106 for the branching ratios B(t→uZ) and B(t→uH), and in the range of 102−104 for the other decays, relative to the Standard Model. We subsequently determine the preferred parameter space regions of the model in terms of potential of being reached in the near future

Seeking heavy Higgs bosons through cascade decays

We investigate the LHC discovery prospects for a heavy Higgs boson decaying into the standard model Higgs boson and additional weak bosons. We consider a generic model-independent new physics configuration where this decay proceeds via a cascade involving other intermediate scalar bosons and focus on an LHC final-state signature comprised either of four b-jets and two charged leptons or of four charged leptons and two b-jets. We design two analyses of the corresponding signals, and demonstrate that a 5?discovery at the 14 TeV LHC is possible for various combinations of the parent and daughter Higgs-boson masses. We moreover find that the standard model backgrounds can be sufficiently rejected to guarantee the reconstruction of the parent Higgs boson mass. We apply our analyses to the Type-II two-Higgs-doublet model and identify the regions of the parameter space to which the LHC is sensitive.by Baradhwaj Coleppa, Benjamin Fuks, P. Poulose and Shibananda Saho