RESUMEN
BACKGROUND: In the clinical literature on abdominal hernia repair, no sound criteria have been established to support the use of biological meshes as opposed to synthetic ones. Furthermore, the information on biological meshes is quite scarce, and so their place in therapy has not yet been defined. METHODS: The treatment of primary and incisional ventral hernia was the target intervention evaluated in our analysis. Our study consisted of the following phases: a) Identification of the biologic meshes available on the market; b) Literature search focused on efficacy and safety of these meshes; c) Analysis of the findings derived from the literature search. The information collected this way was reviewed narratively, and presented according to standard meta-analysis. The main end-points of our analysis included infection of surgical wound at 1 month and recurrence at 12 months. RESULTS: Our clinical literature comprised 11 trials that evaluated 5 biological meshes: Permacol (706 patients), Strattice (324 patients), Surgisis (44 patients), Tutomesh (38 patients) and Xenmatrix (22 patients). These studies generally showed a poor methodological quality. Surgical wound infection showed a wide between-study variability (95%CI: from 12.0% to 22.9%). Also the 12-month relapse rate demonstrated a wide 95%CI (from 5.0% to 19.9%). A significantly lower rate of recurrence at 12 months was found for Permacol compared with Strattice (rate difference: -14.2%; 95%CI: -22.1% to -6.2%). DISCUSSION: Our analysis provided an overview of 5 biological meshes currently available on the market. The different types of meshes showed a marked statistical variability in the clinical outcomes. Hence, nearly all comparisons between different meshes in the two clinical end-points did not reach statistical significance. One exception was represented by the finding that cross-linked meshes had a significantly lower recurrence rate at 12 months than non-cross-linked meshes.
Asunto(s)
Materiales Biocompatibles/uso terapéutico , Hernia Ventral/cirugía , Herniorrafia/métodos , Hernia Incisional/cirugía , Mallas Quirúrgicas/efectos adversos , Materiales Biocompatibles/efectos adversos , Herniorrafia/efectos adversos , Humanos , Recurrencia , Infección de la Herida Quirúrgica/epidemiología , Resultado del TratamientoRESUMEN
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.