Identifying Trauma Patients in Need for Emergency Surgery in the Prehospital Setting: The Prehospital Prediction of In-Hospital Emergency Treatment (PROPHET) Study.

Prehospital field triage often fails to accurately identify the need for emergent surgical or non-surgical procedures, resulting in inefficient resource utilization and increased costs. This study aimed to analyze prehospital factors associated with the need for emergent procedures (such as surgery or interventional angiography) within 6 h of hospital admission. Additionally, our goal was to develop a prehospital triage tool capable of estimating the likelihood of requiring an emergent procedure following hospital admission. We conducted a retrospective observational study, analyzing both prehospital and in-hospital data obtained from the Lombardy Trauma Registry. We conducted a multivariable logistic regression analysis to identify independent predictors of emergency procedures within the first 6 h from admission. Subsequently, we developed and internally validated a triage score composed of factors associated with the probability of requiring an emergency procedure. The study included a total of 3985 patients, among whom 295 (7.4%) required an emergent procedure within 6 h. Age, penetrating injury, downfall, cardiac arrest, poor neurological status, endotracheal intubation, systolic pressure, diastolic pressure, shock index, respiratory rate and tachycardia were identified as predictors of requiring an emergency procedure. A triage score generated from these predictors showed a good predictive power (AUC of the ROC curve: 0.81) to identify patients requiring an emergent surgical or non-surgical procedure within 6 h from hospital admission. The proposed triage score might contribute to predicting the need for immediate resource availability in trauma patients.

Minimally invasive approach to incisional hernia in elective and emergency surgery: a SICE (Italian Society of Endoscopic Surgery and new technologies) and ISHAWS (Italian Society of Hernia and Abdominal Wall Surgery) online survey.

Minimally invasive abdominal wall surgery is growing worldwide, with a constant and fast improvement of surgical techniques and surgeons' confidence in treating both primary and incisional hernias (IH). The Italian Society of Endoscopic Surgery and new technologies (SICE) and the ISHAWS (Italian Society of Hernia and Abdominal Wall Surgery) worked together to investigate state of the art in IH treatment in elective and emergency settings in Italy. An online open survey was designed, and Italian surgeons interested in abdominal wall surgery were invited to fill out a 20-point questionnaire on IH surgical procedures performed in their departments. Surgeons were asked to express their points of view on specific questions about technical and clinical variables in IH treatment. Preferred approach in elective IH surgery was minimally invasive (59.7%). Open surgery was the preferred approach in 40.3% of the responses. In emergency settings, open surgery was the preferred approach (65.4%); however, 34.5% of the involved surgeons declare to prefer the laparoscopic/endoscopic approach. Most respondents opted for conversion to open surgery in case of relevant surgical field contamination, with a non-mesh repair of abdominal wall defects. Among those that used the laparoscopic approach in the emergent setting, the majority (74%) used the size of the defect of 5 cm as a decisional cut-off. The spread of minimally invasive approaches to IH repair in emergency surgery in Italy is gaining relevance. Code-sharing through scientific societies can improve clinical practice in different departments and promote a tailored approach to IH surgery.

Minimally invasive vs. open segmental resection of the splenic flexure for cancer: a nationwide study of the Italian Society of Surgical Oncology-Colorectal Cancer Network (SICO-CNN).

BACKGROUND: Evidence on the efficacy of minimally invasive (MI) segmental resection of splenic flexure cancer (SFC) is not available, mostly due to the rarity of this tumor. This study aimed to determine the survival outcomes of MI and open treatment, and to investigate whether MI is noninferior to open procedure regarding short-term outcomes. METHODS: This nationwide retrospective cohort study included all consecutive SFC segmental resections performed in 30 referral centers between 2006 and 2016. The primary endpoint assessing efficacy was the overall survival (OS). The secondary endpoints included cancer-specific mortality (CSM), recurrence rate (RR), short-term clinical outcomes (a composite of Clavien-Dindo > 2 complications and 30-day mortality), and pathological outcomes (a composite of lymph nodes removed ≧12, and proximal and distal free resection margins length ≧ 5 cm). For these composites, a 6% noninferiority margin was chosen based on clinical relevance estimate. RESULTS: A total of 606 patients underwent either an open (208, 34.3%) or a MI (398, 65.7%) SFC segmental resection. At univariable analysis, OS and CSM were improved in the MI group (log-rank test p = 0.004 and Gray's tests p = 0.004, respectively), while recurrences were comparable (Gray's tests p = 0.434). Cox multivariable analysis did not support that OS and CSM were better in the MI group (p = 0.109 and p = 0.163, respectively). Successful pathological outcome, observed in 53.2% of open and 58.3% of MI resections, supported noninferiority (difference 5.1%; 1-sided 95%CI - 4.7% to ∞). Successful short-term clinical outcome was documented in 93.3% of Open and 93.0% of MI procedures, and supported noninferiority as well (difference - 0.3%; 1-sided 95%CI - 5.0% to ∞). CONCLUSIONS: Among patients with SFC, the minimally invasive approach met the criterion for noninferiority for postoperative complications and pathological outcomes, and was found to provide results of OS, CSM, and RR comparable to those of open resection.

Mass Casualty Incident (MCI) training in a metropolitan university hospital: short-term experience with MAss Casualty SIMulation system MACSIM®.

AIM: The aim of this study was to test and validate a new hospital Mass Casualty Incident (MCI) training using MACSIM® (MAss Casualty SIMulation) system adapted to the specifications and MCI plan of a single hospital. METHODS: The original MCI training format called MACSIM-PEMAF (Piano di Emergenza per il Massiccio Afflusso di Feriti, i.e., hospital disaster plan for massive influx of casualties) was developed for the Italian Society for Trauma and Emergency Surgery (SICUT) in 2016. It uses MACSIM®, a simulation tool for the training and assessment of healthcare professionals in MCI management. Between 2016 and 2018 the course was held several times at a university hospital in the Milan metropolitan area. The MACSIM® tool was used to reproduce different MCI scenarios with actual hospital resources. During the simulations, participants acted in their usual professional functions, testing both the local MCI plan as well as the individuals' knowledge and skills. Course effectiveness was validated by a pre- and post-curse self-assessment questionnaire. RESULTS: MACSIM-PEMAF was tested over 7 courses, with a total of 258 participants. Pre- and post-course questionnaires showed a significant improvement for hospital staff in self-reported perceptions of knowledge and skills in MCI management. In total, on a 1-10 scale, all the staff increased their competencies from a value of 4.4 ± 2.5 to 7.5 ± 1.9 (p < 0.001). CONCLUSION: MACSIM-PEMAF demonstrated efficacy in fulfilling the requirements of Italian law for PEMAF implementation, testing local resources and resilience, as well as increasing the self-reported perception of the hospital staff ability to respond to a MCI.

Biobanking for COVID-19 research.

BACKGROUND: Biobanks are imperative infrastructures, particularly during outbreaks, when there is an obligation to acquire and share knowledge as quick as possible to allow for implementation of science-based preventive, diagnostic, prognostic, and therapeutic strategies. METHODS: We established a COVID-19 biobank with the aim of collecting high-quality and well-annotated human biospecimens, in the effort to understand the pathogenic mechanisms underlying COVID-19 and identify therapeutic targets (COVID-BioB, NCT04318366). Here we describe our experience and briefly review the characteristics of the biobanks for COVID-19 that have been so far established. RESULTS: A total of 46,677 samples have been collected from 913 participants (63.3% males, median [IQR] age 62.2 [51.2-74.0] years) since the beginning of the program. Most patients (66.9%) had been admitted to hospital for COVID-19, with a median length of stay of 15.0 (9.0-27.0) days. A minority of patients (13.3% of the total) had been admitted for other reasons and subsequently tested positive for SARS-CoV-2. The remainder were managed at home after being seen at the Emergency Department. CONCLUSIONS: Having a solid research infrastructure already in place, along with flexibility and adaptability to new requirements, allowed for the quick building of a COVID-19 biobank that will help expand and share the knowledge of SARS-CoV-2.

Evaluation of Interaction Between Emergency Medical System and Hospital Network During a Train Derailment in Milano.

On January 25, 2018 a 5-car train derailed in Pioltello, 10 kilometers North-East of Milano City. A standardized post-hoc form was distributed to the hospitals involved in the management of the victims and allowed for an evaluation of the response to the incident.The management of the incident by EMS (Emergency Medical System) was effective in terms of organization of the scene and distribution of the patients, although the time for the first severe patient to reach the closest appropriate hospital was very long (2 hours). This can be partially explained by the extrication time.None of the alerted hospitals exceeded their capacity, as patients were distributed carefully among the hospitals. The overall outcome was quite satisfactory; no deaths were reported except for those on scene. Some responding hospitals reported that there was an over-activation based on the services ultimately needed. However this is common in MCIs, as an over-activation is preferable to an under-estimation. To address this concern, as more data are available, activation should be scaled down based on a plan established prior to it; this mechanism of scaling down seems to have failed in this event.It is of note that the highest performing hospitals underwent recently to an educational program on MCI management.

Assessing Hospital Adaptive Resource Allocation Strategies in Responding to Mass Casualty Incidents.

OBJECTIVES: Hospitals are expected to operate at a high-performance level even under exceptional conditions of peak demand and resource disruptions. This understanding is not mature yet, and there are wide areas of possible improvement. In particular, the fast mobilization and reconfiguration of resources frequently result into the severe disruption of elective activities, worsening the quality of care. More resilient resource allocation strategies, ie, which adapt to the dynamics of the prevailing circumstance, are needed to maximize the effectiveness of health-care delivery. In this study, a simulation approach was adopted to assess and compare different hospital's adaptive resource allocation strategies in responding to a mass casualty incident (MCI). METHODS: A specific set of performance metrics was developed to take into consideration multiple objectives and priorities and holistically assess the effectiveness of health-care delivery when coping with an MCI event. Discrete event simulation (DES) and system dynamics (SD) were used to model the key hospital processes and the MCI plan. RESULTS: In the daytime scenario, during the recovery phase of the emergency, a gradual disengagement of resources from the emergency department (ED) to restart ordinary activities in operating rooms and wards, returned the best performance. In the night scenario, the absorption capacity of the ED was evaluated by identifying the current bottleneck and assessment of the benefit of different resource mobilization strategies. CONCLUSIONS: The present study offers a robust approach, effective strategies, and new insights to design more resilient plans to cope with MCIs. Future research is needed to widen the scope of the analysis and take into consideration additional resilience capacities, such as operational coordination mechanisms, among multiple hospitals in the same geographic area.

Impact of the COVID-19 outbreak on severe trauma trends and healthcare system reassessment in Lombardia, Italy: an analysis from the regional trauma registry.

BACKGROUNDS: The COVID-19 pandemic drastically strained the health systems worldwide, obligating the reassessment of how healthcare is delivered. In Lombardia, Italy, a Regional Emergency Committee (REC) was established and the regional health system reorganized, with only three hospitals designated as hubs for trauma care. The aim of this study was to evaluate the effects of this reorganization of regional care, comparing the distribution of patients before and during the COVID-19 outbreak and to describe changes in the epidemiology of severe trauma among the two periods. METHODS: A cohort study was conducted using retrospectively collected data from the Regional Trauma Registry of Lombardia (LTR). We compared the data of trauma patients admitted to three hub hospitals before the COVID-19 outbreak (September 1 to November 19, 2019) with those recorded during the pandemic (February 21 to May 10, 2020) in the same hospitals. Demographic data, level of pre-hospital care (Advanced Life Support-ALS, Basic Life Support-BLS), type of transportation, mechanism of injury (MOI), abbreviated injury score (AIS, 1998 version), injury severity score (ISS), revised trauma score (RTS), and ICU admission and survival outcome of all the patients admitted to the three trauma centers designed as hubs, were reviewed. Screening for COVID-19 was performed with nasopharyngeal swabs, chest ultrasound, and/or computed tomography. RESULTS: During the COVID-19 pandemic, trauma patients admitted to the hubs increased (46.4% vs 28.3%, p < 0.001) with an increase in pre-hospital time (71.8 vs 61.3 min, p < 0.01), while observed in hospital mortality was unaffected. TRISS, ISS, AIS, and ICU admission were similar in both periods. During the COVID-19 outbreak, we observed substantial changes in MOI of severe trauma patients admitted to three hubs, with increases of unintentional (31.9% vs 18.5%, p < 0.05) and intentional falls (8.4% vs 1.2%, p < 0.05), whereas the pandemic restrictions reduced road- related injuries (35.6% vs 60%, p < 0.05). Deaths on scene were significantly increased (17.7% vs 6.8%, p < 0.001). CONCLUSIONS: The COVID-19 outbreak affected the epidemiology of severe trauma patients. An increase in trauma patient admissions to a few designated facilities with high level of care obtained satisfactory results, while COVID-19 patients overwhelmed resources of most other hospitals.

Assessing Hospital Adaptive Resource Allocation Strategies in Responding to Mass Casualty Incidents.

BACKGROUND: Hospitals are expected to operate at a high performance level even under exceptional conditions of peak demand and resource disruptions. This understanding is not mature yet and there are wide areas of possible improvement. In particular, the fast mobilization and reconfiguration of resources frequently result into the severe disruption of elective activities, worsening the quality of care. This becomes particularly evident during the on-going coronavirus disease 2019 (COVID-19) pandemic. More resilient resource allocation strategies, that is, which adapt to the dynamics of the prevailing circumstance, are needed to maximize the effectiveness of health-care delivery. In this study, a simulation approach was adopted to assess and compare different hospital's adaptive resource allocation strategies in responding to a sudden onset disaster mass casualty incident (MCI). METHODS: A specific set of performance metrics was developed to take into consideration multiple objectives and priorities and holistically assess the effectiveness of health-care delivery when coping with an MCI event. Discrete event simulation (DES) and system dynamics (SD) were used to model the key hospital processes and the MCI plan. RESULTS: In the daytime scenario, during the recovery phase of the disaster, a gradual disengagement of resources from the emergency department (ED) to restart ordinary activities in operating rooms and wards returned the best performance. In the night scenario, the absorption capacity of the ED was evaluated by identifying the current bottleneck and assessment of the benefit of different resource mobilization strategies. CONCLUSIONS: The present study offers a robust approach, effective strategies and new insights to design more resilient plans to cope with MCIs. It becomes particularly relevant when considering the risk of indirect damage of emergencies, where all the available resources are shifted from the care of the ordinary to the "disaster" patients, like during the on-going COVID-19 pandemic. Future research is needed to widen the scope of the analysis and take into consideration additional resilience capacities such as operational coordination mechanisms among multiple hospitals in the same geographic area.

High sensitivity of ROSE-supported ERCP-guided brushing for biliary strictures.

Background and study aims Endoscopic retrograde cholangiopancreatography (ERCP) plays a major role in biliary strictures, with brushing being a cheap and fast method to acquire a cytological specimen, despite a sensitivity around 45 %. Rapid on-site evaluation (ROSE) is widely used for endoscopic ultrasound-acquired cytological specimen adequacy, improving its sensitivity and specificity. Nevertheless, no study has evaluated its role for ERCP-guided brushing. Our aim was to assess the diagnostic yield of ERCP-guided brushing of biliary strictures when supported by ROSE. Patients and methods This was a retrospective single-center study that included patients undergoing ERCP-guided brush cytology supported by ROSE for biliary strictures. Recorded data included patient clinical-radiological and ERCP features. Final diagnosis was determined after surgery, intraductal biopsy or adequate follow-up. The diagnostic yield was calculated and a subgroup analysis for factors associated with false-negative or true-positive results was performed. Results Two hundred six patients were included, 57.3 % males, median age 72 years, 77.2 % having extrahepatic biliary strictures. Of the patients, 99 % had an adequate sample at ROSE after a mean of 2.6 passages. The diagnostic yield was accuracy 83 %, sensitivity 74.6 %, and specificity 98 %, positive and negative predictive values 98 % and 71 % respectively, with an area under the curve of 0.86. A diagnosis of cholangiocarcinoma was significantly more frequent among true-positive cases (68 % vs 46.8 %; P  = 0.04). Conclusions This is the first study evaluating the use of ROSE as support for ERCP-guided brushing of biliary strictures, with a sensitivity far higher than those reported for brushing alone and at least comparable to those of more expensive and invasive techniques.

Pulmonary Vascular Thrombosis in COVID-19 Pneumonia.

OBJECTIVES: During severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, dramatic endothelial cell damage with pulmonary microvascular thrombosis have been was hypothesized to occur. The aim was to assess whether pulmonary vascular thrombosis (PVT) is due to recurrent thromboembolism from peripheral deep vein thrombosis or to local inflammatory endothelial damage, with a superimposed thrombotic late complication. DESIGN: Observational study. SETTING: Medical and intensive care unit wards of a teaching hospital. PARTICIPANTS: The authors report a subset of patients included in a prospective institutional study (CovidBiob study) with clinical suspicion of pulmonary vascular thromboembolism. INTERVENTIONS: Computed tomography pulmonary angiography and evaluation of laboratory markers and coagulation profile. MEASUREMENTS AND MAIN RESULTS: Twenty-eight of 55 (50.9%) patients showed PVT, with a median time interval from symptom onset of 17.5 days. Simultaneous multiple PVTs were identified in 22 patients, with bilateral involvement in 16, mostly affecting segmental/subsegmental pulmonary artery branches (67.8% and 96.4%). Patients with PVT had significantly higher ground glass opacity areas (31.7% [22.9-41] v 17.8% [10.8-22.1], p < 0.001) compared with those without PVT. Remarkably, in all 28 patients, ground glass opacities areas and PVT had an almost perfect spatial overlap. D-dimer level at hospital admission was predictive of PVT. CONCLUSIONS: The findings identified a specific radiologic pattern of coronavirus disease 2019 (COVID-19) pneumonia with a unique spatial distribution of PVT overlapping areas of ground-glass opacities. These findings supported the hypothesis of a pathogenetic relationship between COVID-19 lung inflammation and PVT and challenged the previous definition of pulmonary embolism associated with COVID-19 pneumonia.

Stranger Months: How SARS-CoV-2, Fear of Contagion, and Lockdown Measures Impacted Attendance and Clinical Activity During February and March 2020 at an Urban Emergency Department in Milan.

OBJECTIVES: An unprecedented wave of patients with acute respiratory failure due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease 2019 (COVID-19) hit emergency departments (EDs) in Lombardy, starting in the second half of February 2020. This study describes the direct and indirect impacts of the SARS-CoV-2 outbreak on an urban major-hospital ED. METHODS: Data regarding all patients diagnosed with COVID-19 presenting from February 1 to March 31, 2020, were prospectively collected, while data regarding non-COVID patients presenting within the same period in 2019 were retrospectively retrieved. RESULTS: ED attendance dropped by 37% in 2020. Two-thirds of this reduction occurred early after the identification of the first autochthonous COVID-19 case in Lombardy, before lockdown measures were enforced. Hospital admissions of non-COVID patients fell by 26%. During the peak of COVID-19 attendance, the ED faced an extraordinary increase in: patients needing oxygen (+239%) or noninvasive ventilation (+725%), transfers to the intensive care unit (+57%), and in-hospital mortality (+309%), compared with the same period in 2019. CONCLUSIONS: The COVID-19 outbreak determined an unprecedented upsurge in respiratory failure cases and mortality. Fear of contagion triggered a spontaneous, marked reduction of ED attendance, and, presumably, some as yet unknown quantity of missed or delayed diagnoses for conditions other than COVID-19.

Early predictors of clinical outcomes of COVID-19 outbreak in Milan, Italy.

BACKGROUND: National health-system hospitals of Lombardy faced a heavy burden of admissions for acute respiratory distress syndromes associated with coronavirus disease (COVID-19). Data on patients of European origin affected by COVID-19 are limited. METHODS: All consecutive patients aged ≥18 years, coming from North-East of Milan's province and admitted at San Raffaele Hospital with COVID-19, between February 25th and March 24th, were reported, all patients were followed for at least one month. Clinical and radiological features at admission and predictors of clinical outcomes were evaluated. RESULTS: Of the 500 patients admitted to the Emergency Unit, 410 patients were hospitalized and analyzed: median age was 65 (IQR 56-75) years, and the majority of patients were males (72.9%). Median (IQR) days from COVID-19 symptoms onset was 8 (5-11) days. At hospital admission, fever (≥ 37.5 °C) was present in 67.5% of patients. Median oxygen saturation (SpO2) was 93% (range 60-99), with median PaO2/FiO2 ratio, 267 (IQR 184-314). Median Radiographic Assessment of Lung Edema (RALE) score was 9 (IQR 4-16). More than half of the patients (56.3%) had comorbidities, with hypertension, coronary heart disease, diabetes and chronic kidney failure being the most common. The probability of overall survival at day 28 was 66%. Multivariable analysis showed older age, coronary artery disease, cancer, low lymphocyte count and high RALE score as factors independently associated with an increased risk of mortality. CONCLUSION: In a large cohort of COVID-19 patients of European origin, main risk factors for mortality were older age, comorbidities, low lymphocyte count and high RALE.

European Society of Trauma and Emergency Surgery (ESTES) recommendations for trauma and emergency surgery preparation during times of COVID-19 infection.

A series of recommendations regarding hospital perioperative preparation for the COVID-19 pandemic were compiled to inform surgeons worldwide on how to provide emergency surgery and trauma care during enduring times.The recommendations are divided into eight domains: (1) General recommendation for surgical services; (2) Emergency Surgery for critically ill COVID-19 positive or suspected patients -Preoperative planning and case selection; (3) Operating Room setup; (4) patient transport to the OR; (5) Surgical staff preparation; (6) Anesthesia considerations; (7) Surgical approach; and (8) Case Completion.The European Society of Emergency Surgery board endorsed these recommendations.

Clinicopathological Factors Influencing Lymph Node Yield in Colorectal Cancer: A Retrospective Study.

Many colorectal resections do not meet the minimum of 12 lymph nodes (LNs) recommended by the American Joint Committee on Cancer for accurate staging of colorectal cancer. The aim of this study was to investigate factors affecting the number of the adequate nodal yield in colorectal specimens subject to routine pathological assessment. We have retrospectively analysed the data of 2319 curatively resected colorectal cancer patients in San Raffaele Scientific Institute, Milan, between 1993 and 2017 (1259 colon cancer patients and 675 rectal cancer patients plus 385 rectal cancer patients who underwent neoadjuvant therapy). The factors influencing lymph node retrieval were subjected to uni- and multivariate analyses. Moreover, a survival analysis was carried out to verify the prognostic implications of nodal counts. The mean number of evaluated nodes was 24.08 ± 11.4, 20.34 ± 11.8, and 15.33 ± 9.64 in surgically treated right-sided colon cancer, left-sided colon cancer, and rectal tumors, respectively. More than 12 lymph nodes were reported in surgical specimens in 1094 (86.9%) cases in the colon cohort and in 425 (63%) cases in the rectal cohort, and patients who underwent neoadjuvant chemoradiation were analysed separately. On univariate analysis of the colon cancer group, higher LNs counts were associated with female sex, right colon cancer, emergency surgery, pT3-T4 diseases, higher tumor size, and resected specimen length. On multivariate analysis right colon tumors, larger mean size of tumor, length of specimen, pT3-T4 disease, and female sex were found to significantly affect lymph node retrieval. Colon cancer patients with 12 or more lymph nodes removed had a significantly better long-term survival than those with 11 or fewer nodes (P = 0.002, log-rank test). Rectal cancer patients with 12 or more lymph nodes removed approached but did not reach a statistically different survival (P = 0.055, log-rank test). Multiple tumor and patients' factors are associated with lymph node yield, but only the removal of at least 12 lymph nodes will reliably determine lymph node status.

SIRS or qSOFA? Is that the question? Clinical and methodological observations from a meta-analysis and critical review on the prognostication of patients with suspected sepsis outside the ICU.

The purpose of the study was to assess the prognostic performances, in terms of in-hospital mortality, of the quick sequential organ failure assessment (qSOFA) score and the systemic inflammatory response syndrome (SIRS) criteria applied to patients with suspected infection outside the ICU, and to critically reappraise the results and the clinical impact of the SEPSIS-3 study and of the subsequent trials. We performed bivariate meta-analysis, evaluation of the Bayesian post-test probabilities of death, and computation of the unidentified deaths for every 1000 screened cases (UDS1000). The use of qSOFA for screening instead of the SIRS implies a relevant increase in the UDS1000. However, this difference appears far smaller in the SEPSIS-3 study, largely due to an underestimation of SIRS sensitivity. The increment in the pre-test probability of death implied by a positive qSOFA is higher than that implied by a positivity of the SIRS. However, the included studies use highly variable definitions of "suspected sepsis" and carry very high levels of heterogeneity. SIRS overperforms qSOFA as a rule-out tool for mortality, while qSOFA shows a higher rule-in power. However, the evident lack of consistency across the published studies undermines the significance of both the meta-analytic approach and the reproducibility of the outcomes, and demands for a standardized definition of the target population.

Defining the characteristics of certified hernia centers in Italy: The Italian society of hernia and abdominal wall surgery workgroup consensus on systematic reviews of the best available evidences.

BACKGROUND: The terms "Hernia Center" (HC) and Hernia Surgeon" (HS) have gained more and more popularity in recent years. Nevertheless, there is lack of protocols and methods for certification of their activities and results. The Italian Society of Hernia and Abdominal Wall Surgery proposes a method for different levels of certification. METHODS: The national board created a commission, with the task to define principles and structure of an accreditation program. The discussion of each topic was preceded by a Systematic Review, according to PRISMA Guidelines and Methodology. In case of lack or inadequate data from literature, the parameter was fixed trough a Commission discussion. RESULTS: The Commission defined a certification process including: "FLC - First level Certification": restricted to single surgeon, it is given under request and proof of a formal completion of the learning curve process for the basic procedures and an adequate year volume of operations. "Second level certification": Referral Center for Abdominal Wall Surgery. It is a public or private structure run by at least two already certified and confirmed FLC surgeons. "Third level certification": High Specialization Center for Abdominal Wall Surgery. It is a public or private structure, already confirmed as Referral Centers, run by at least three surgeons (two certified and confirmed with FLC and one research fellow in abdominal wall surgery). Both levels of certification have to meet the Surgical Requirements and facilities criteria fixed by the Commission. CONCLUSION: The creation of different types of Hernia Centers is directed to create two different entities offering the same surgical quality with separate mission: the Referral Center being more dedicated to clinical and surgical activity and High Specialization Centers being more directed to scientific tasks.