Prevention of incisional hernia after midline laparotomy with prophylactic mesh reinforcement: a meta-analysis and trial sequential analysis.

BACKGROUND: Incisional hernia is a frequent complication after abdominal surgery. The aim of this study was to assess the efficacy of prophylactic mesh reinforcement (PMR) after midline laparotomy in reducing the incidence of incisional hernia. METHODS: A meta-analysis was conducted following PRISMA guidelines. The primary outcome was the incidence of incisional hernia after follow-up of at least 12 months. Secondary outcomes were postoperative complications. Only RCTs were included. A random-effects model was used for the meta-analysis, and trial sequential analysis was conducted. RESULTS: Twelve RCTs were included, comprising 1815 patients. The incidence of incisional hernia was significantly lower after PMR compared with sutured closure (risk ratio (RR) 0·35, 95 per cent c.i. 0·21 to 0·57; P < 0·001). Both onlay (RR 0·26, 0·11 to 0·67; P = 0·005) and retromuscular (RR 0·28, 0·10 to 0·82; P = 0·02) PMR led to a significant reduction in the rate of incisional hernia. The occurrence of seroma was higher in patients who had onlay PMR (RR 2·23, 1·10 to 4·52; P = 0·03). PMR did not result in an increased rate of surgical-site infection. CONCLUSION: PMR of a midline laparotomy using an onlay or retromuscular technique leads to a significant reduction in the rate of incisional hernia in high-risk patients. Individual risk factors should be taken into account to select patients who will benefit most. [Correction added on 19 February 2020, after first online publication: J. García Alamino has been amended to J. M. Garcia-Alamino].

ANTECEDENTES: La eventración (hernia incisional) es una complicación frecuente de la cirugía abdominal. El objetivo es evaluar la eficacia de la inserción de una malla profiláctica de refuerzo (prophylactic mesh reinforcement, PMR) después de la laparotomía media para reducir la incidencia de eventración. MÉTODOS: Se realizó un metaanálisis siguiendo las recomendaciones PRISMA. La variable principal fue la incidencia de eventración después de un seguimiento mínimo de 12 meses. Las variables secundarias fueron las complicaciones postoperatorias. Solo se incluyeron ensayos controlados aleatorizados. Se utilizó un modelo de efectos aleatorios para el metaanálisis y se realizó un análisis secuencial de los ensayos. RESULTADOS: Se incluyeron 12 ensayos aleatorizados y controlados con 1.815 pacientes. La incidencia de eventración fue significativamente menor después de la PMR en comparación con el cierre simple (riesgo relativo, RR 0,35; i.c. del 95%: 0,21-0,57, P < 0,0001). Hubo una reducción significativa de la tasa de eventración tanto si la PMR se colocó en posición supra-aponeurótica (RR 0,26; i.c. del 95% 0,11-0,67, P = 0,005) como retromuscular (RR 0,28; i.c. del 95% 0,0-0,82, P = 0,02). La aparición de seromas fue mayor en los pacientes con RPM supra-aponeurótica (RR 2,23; i.c. del 95% 1,10-4,52, P = 0,03). La PMR no conllevó una mayor tasa de infecciones de la herida quirúrgica. CONCLUSIÓN: Una PMR en una laparotomía de la línea media, tanto en posición supra-aponeurótica como retromuscular, reduce de forma significativa el desarrollo de eventraciones en pacientes de alto riesgo. Se deben considerar los factores de riesgo individuales para seleccionar a los pacientes que más puedan beneficiarse.

A post-market, prospective, multi-center, single-arm clinical investigation of Phasix™ mesh for VHWG grade 3 midline incisional hernia repair: a research protocol.

BACKGROUND: Incisional heia is a frequent complication of midline laparotomy. The use of mesh in hernia repair has been reported to lead to fewer recurrences compared to primary repair. However, in Ventral Hernia Working Group (VHWG) Grade 3 hernia patients, whose hernia is potentially contaminated, synthetic mesh is prone to infection. There is a strong preference for resorbable biological mesh in contaminated fields, since it is more able to resist infection, and because it is fully resorbed, the chance of a foreign body reaction is reduced. However, when not crosslinked, biological resorbable mesh products tend to degrade too quickly to facilitate native cellular ingrowth. Phasix™ Mesh is a biosynthetic mesh with both the biocompatibility and resorbability of a biological mesh and the mechanical strength of a synthetic mesh. This multi-center single-arm study aims to collect data on safety and performance of Phasix™ Mesh in Grade 3 hernia patients. METHODS: A total of 85 VHWG Grade 3 hernia patients will be treated with Phasix™ Mesh in 15 sites across Europe. The primary outcome is Surgical Site Occurrence (SSO) including hematoma, seroma, infection, dehiscence and fistula formation (requiring intervention) through 3 months. Secondary outcomes include recurrence, infection and quality of life related outcomes after 24 months. Follow-up visits will be at drain removal (if drains were not placed, then on discharge or staple removal instead) and in the 1st, 3rd, 6th, 12th, 18th and 24th month after surgery. CONCLUSION: Based on evidence from this clinical study Depending on the results this clinical study will yield, Phasix™ Mesh may become a preferred treatment option in VHWG Grade 3 patients. TRIAL REGISTRATION: The trial was registered on March 25, 2016 on clinicaltrials.gov: NCT02720042 .

Characteristics of different mesh types for abdominal wall repair in an experimental model of peritonitis.

BACKGROUND: The use of synthetic mesh to repair a potentially contaminated incisional hernia may lead to higher failure rates. A biological mesh might be considered, but little is known about long-term results. Both biological and synthetic meshes were investigated in an experimental model of peritonitis to assess their characteristics in vivo. METHODS: Male Wistar rats were randomized into five groups and peritonitis was induced. A mesh was implanted after 24 h. Five meshes were investigated: Permacol™ (cross-linked collagen), Strattice™ (non-cross-linked collagen), XCM Biologic® (non-cross-linked collagen), Omyra® Mesh (condensed polytetrafluoroethylene) and Parietene™ (polypropylene). The rats were killed after either 30, 90 or 180 days. Incorporation and shrinkage of the mesh, adhesion coverage, strength of adhesions and histology were analysed. RESULTS: Of 135 rats randomized, 18 died from peritonitis. Some 180 days after implantation, both XCM Biologic® and Permacol™ had significantly better incorporation than Strattice™ (P = 0·003 and P = 0·009 respectively). Strattice™ had significantly fewer adhesions than XCM Biologic® (P = 0·001) and Permacol™ (P = 0·020). Thirty days after implantation, Permacol™ had significantly stronger adhesions than Strattice™ (P < 0·001). Shrinkage was most prominent in XCM Biologic® , but no significant difference was found compared with the other meshes. Histological analysis revealed marked differences in foreign body response among all meshes. CONCLUSION: This experimental study suggested that XCM Biologic® was superior in terms of incorporation, macroscopic mesh infection, and histological parameters such as collagen deposition and neovascularization. There must be sufficient overlap of mesh during placement, as XCM Biologic® showed a high rate of shrinkage. Surgical relevance The use of synthetic mesh to repair a potentially contaminated incisional hernia is not supported unequivocally, and may lead to a higher failure rate. A biological mesh might be considered as an alternative. There are few long-term studies, as these meshes are expensive and rarely used. This study evaluated the use of biological mesh in a contaminated environment, and investigated whether there is an ideal mesh. A new non-cross-linked biological mesh (XCM Biologic® ) was evaluated in this experiment. The new non-cross-linked biological mesh XCM Biologic® performed best and may be useful in patients with a potentially contaminated incisional hernia.

The feasibility of local anesthesia for the surgical treatment of umbilical hernia: a systematic review of the literature.

BACKGROUND: Yearly approximately 4500 umbilical hernias are repaired in The Netherlands, mostly under general anesthesia. The use of local anesthesia has shown several advantages in groin hernia surgery. Local anesthesia might be useful in the treatment of umbilical hernia as well. However, convincing evidence is lacking. We have conducted a systematic review on safety, feasibility, and advantages of local anesthesia for umbilical hernia repair. METHODS: A systematic review was conducted according to the PRISMA guidelines. Outcome parameters were duration of surgery, surgical site infection, perioperative and postoperative complications, postoperative pain, hernia recurrence, time before discharge, and patient satisfaction. RESULTS: The systematic review resulted in nine included articles. Various anesthetic agents were used, varying from short acting to longer acting agents. There was no consensus regarding the injection technique and no conversions to general anesthesia were described. The most common postoperative complication was surgical site infection, with an overall percentage of 3.4%. There were no postoperative deaths and no allergic reactions described for local anesthesia. The hernia recurrence rate varied from 2 to 7.4%. Almost 90% of umbilical hernia patients treated with local anesthesia were discharged within 24 h, compared with 47% of patients treated with general anesthesia. The overall patient satisfaction rate varied from 89 to 97%. CONCLUSION: Local anesthesia for umbilical hernia seems safe and feasible. However, the advantages of local anesthesia are not sufficiently demonstrated, due to the heterogeneity of included studies. We, therefore, propose a randomized controlled trial comparing general versus local anesthesia for umbilical hernia repair.