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.

Outcomes of the open mesh repair of large incisional hernias using an intraperitoneal composite mesh: our experience with 100 cases.

Incisional hernia repair sometimes requires intraperitoneal implantation of a mesh. This becomes necessary when the hernia opening is large, in particular, in patients with a low abdominal wall surface/wall defect surface (AWS/WDS) ratio, in large boundary incisional hernias where the proximity to bone structures or cartilage often complicates retromuscular mesh implantation and in multi-recurrent incisional hernias that are sometimes characterised by an actual loss of abdominal wall tissue. The authors report on the results of a series of 100 incisional hernias treated between 1999 and 2006 using the open technique to implant an intraperitoneal mesh (Parietex Composite). Mean follow-up time was 42 months (range 12-96 months). The mean wall defect surface was 95 cm(2) (range 60-210 cm(2)). Twelve percent of patients suffered minor complications: 5 seromas (5%), 3 haematomas (3%) and 4 parietal suppurations (4%). No mesh had to be removed. The recurrence rate was 6%. At 6 months after surgery, no patient lamented pain or discomfort due to foreign body sensation. None of these patients presented intestinal occlusion or enterocutaneous fistulae. In conclusion, it is our opinion that the mesh should be implanted in direct contact with the viscera only where absolutely necessary, i.e., when it cannot be implanted in the retromuscular area without creating excessive parietal tension. Our experience with PC mesh, over the short-to-medium term, was positive. Naturally, further studies are required to evaluate long-term biocompatibility.

The use of bovine pericardial strips on linear stapler to reduce extraluminal bleeding during laparoscopic gastric bypass: prospective randomized clinical trial.

BACKGROUND: A prospective comparison was conducted of extraluminal bleeding following gastric transection with or without staple-line reinforcement by dehydrated bovine pericardium (Peri-Strips Dry--PSD) during laparoscopic Roux-en-Y gastric bypass (LRYGBP). METHODS: From January 2001 to September 2003, 98 consecutive morbidly obese patients underwent LRYGBP. Patients were randomly allocated to 2 groups according to the use (Group A, n= 50) or not (Group B, n= 48) of Peri-Strips Dry. In both groups, mortality, intra- and postoperative early and late complications, operating-time, number of hemostatic clips used, blood transfusion and any specific event directly related to the prosthetic material were prospectively evaluated. Data were expressed as mean +/- SD except as otherwise indicated. Statistical analysis was done by means of Student t-test and Fisher exact test. P-value cut off for statistical significance was set at 0.05. RESULTS: Intra- and postoperative mortality were absent. Intra-operative methylene blue test was positive in 6/48 (12.5%) of Group B patients (P<0.001). Overall laparotomic conversion was 3/98 patients (3.1%). One/48 Group B patient was converted because of unsatisfactory exposure and one for linear stapler misfire. One/50 Group A patients was converted for short gastric vessels bleeding during dissection. No patients were re-operated or transfused because of extraluminal bleeding. Mean number of clips used was significantly lower in Group A patients (5 vs 23, P<0.001). The operating-time was significantly less in Group A patients (120+/-60 vs 220+/-100 minutes, P<0.01). CONCLUSIONS: Gastric staple-lines reinforced with Peri-Strips Dry result in a significant reduction in the number of Endo-clips used and prevent bleeding. A dry operating field was obtained, and operating-time was significantly reduced. No adverse events could be related to the use PSD.