Clinical outcomes and quality of life associated with the use of a biosynthetic mesh for complex ventral hernia repair: analysis of the "Italian Hernia Club" registry.

With the development of newer meshes and approaches to hernia repair, it is currently difficult to evaluate their performances while considering the patients' perspective. The aim of the study was to assess the clinical outcomes and quality of life consequences of abdominal hernia repairs performed in Italy using Phasix and Phasix ST meshes through the analysis of real-world data to support the choice of new generation biosynthetic meshes. An observational, prospective, multicentre study was conducted in 10 Italian clinical centres from May 2015 to February 2018 and in 15 Italian clinical centres from March 2018 to May 2019. The evaluation focused on patients with VHWG grade II-III who underwent primary ventral hernia repair or incisional hernia intervention with a follow-up of at least 18 months. Primary endpoints included complications' rates, and secondary outcomes focused on patient quality of life as measured by the EuroQol questionnaire. Seventy-five patients were analysed. The main complications were: 1.3% infected mesh removal, 4.0% superficial infection requiring procedural intervention, 0% deep/organ infection, 8.0% recurrence, 5.3% reintervention, and 6.7% drained seroma. The mean quality of life utility values ranged from 0.768 (baseline) to 0.967 (36 months). To date, Phasix meshes have proven to be suitable prostheses in preventing recurrence, with promising outcomes in terms of early and late complications and in improving patient quality of life.

Budget Impact Analysis of a Biosynthetic Mesh for Incisional Hernia Repair.

PURPOSE: With the development of newer prostheses for hernia repair, it is nowadays difficult to understand the total cost of managing patients treated with these advanced medical devices, especially in the complex abdomen, in which various complications may occur. The aim of this study was to determine the economic implications of these prostheses in order to inform decision making in the management of incisional hernia repair. METHODS: A budget impact analysis model was developed to evaluate the economic consequences related to the management of patients undergoing complex (Centers for Disease Control and Prevention wound class II-III or Ventral Hernia Working Group grade 2/3) incisional hernia repair through biosynthetic, synthetic, or biological meshes, from the hospital perspective in Italy. The model was populated with complication rates mainly retrieved from the literature to compare the current scenario with 60%, 10%, and 30% rates of synthetic, biosynthetic, and biological mesh utilization, respectively, with future hypothetical scenarios that consider increasing rates of biosynthetic mesh utilization with respect to the other types of mesh in the next 5 years. Hospital costs of the different events were estimated based on health care resource consumption derived from an electronic survey addressed to key opinion leaders in the field. FINDINGS: The analysis compared the current scenario with future hypothetical scenarios that consider increasing utilization rates of biosynthetic meshes of 25%, 38%, and 44% in the next 1, 3, and 5 years, as estimated by clinicians. Considering 40,000 incisional hernia repairs per year, an increasing use of the biosynthetic meshes may result in a decrease in the total hospital budget of about €153 million in the next 5 years, with a savings per patient of about €770. IMPLICATIONS: The findings of this study support the use of biosynthetic meshes for complex abdominal wall repairs in Italy, showing a potential decrease in the hospital budget in Italy after the diffusion of the new biosynthetic prostheses. Further studies and data from clinical practice would provide additional information to increase the understanding of the economic sustainability of these advanced devices.

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.

Italian Biological Prosthesis Work-Group (IBPWG): proposal for a decisional model in using biological prosthesis.

INTRODUCTION: Indications for repair of abdominal hernia are well established and widely diffused. Controversies still exist about the indication in using the different prosthetic materials and principally about the biological ones. MATERIAL AND METHODS: In February 2012, the Italian Biological Prosthesis Work-Group (IBPWG), counting a background of 264 biologic implants, met in Bergamo (Italy) for 1-day meeting with the aim to elaborate a decisional model on biological prosthesis use in abdominal surgery. RESULTS: A diagram to simplify the decisional process in using biologics has been elaborated. CONCLUSION: The present score represents a first attempt to combine scientific knowledge and clinical expertise in order to offer precise indications about the kind of biological mesh to use.

Stop Flow in abdominal and pelvic cancer relapses.

To determinate MTD, DLT and safe doses for phase II study, a dose finding study with Mitomycin and Adriamycin Stop-Flow administration was carried out. A phase II study focused on resectability of pelvic colorectal relapses is in progress. From November 1995, 84 pts, 52 male and 32 female (94 treatments), with advanced not resectable abdominal (14 pts) or pelvic (70 pts) relapses, and resistant to previous systemic chemotherapy, were enrolled in the study. 46 pts entered the phase I-early phase II study, while subsequently 38 pts were recruited in ongoing phase II study. Safe dose were: MMC 20 mg/mq and ADM 75 mg/mq. The phase II study focused on colorectal relapses registered very promising responses: 90% pain control, 1 pCR and 26 PR / 63 (OR 43%), 8 NC (13%) 9/27 responder patients (33%) obtained a complete resectability of colorectal relapses. Stop-Flow is a safe and feasible technique very useful as a palliation treatment.