Five-Year Follow-Up of a Slowly Resorbable Biosynthetic P4HB Mesh (Phasix) in VHWG Grade 3 Incisional Hernia Repair.

Objective: To assess the 5-year recurrence rate of incisional hernia repair in Ventral Hernia Working Group (VHWG) 3 hernia with a slowly resorbable mesh. Summary Background Data: Incisional hernia recurs frequently after initial repair. In potentially contaminated hernia, recurrences rise to 40%. Recently, the biosynthetic Phasix mesh has been developed that is resorbed in 12-18 months. Resorbable meshes might be a solution for incisional hernia repair to decrease short- and long-term (mesh) complications. However, long-term outcomes after resorption are scarce. Methods: Patients with VHWG grade 3 incisional midline hernia, who participated in the Phasix trial (Clinilcaltrials.gov: NCT02720042) were included by means of physical examination and computed tomography (CT). Primary outcome was hernia recurrence; secondary outcomes comprised of long-term mesh complications, reoperations, and abdominal wall pain [visual analogue score (VAS): 0-10]. Results: In total, 61/84 (72.6%) patients were seen. Median follow-up time was 60.0 [interquartile range (IQR): 55-64] months. CT scan was made in 39 patients (68.4%). A recurrence rate of 15.9% (95% confidence interval: 6.9-24.8) was calculated after 5 years. Four new recurrences (6.6%) were found between 2 and 5 years. Two were asymptomatic. In total, 13/84 recurrences were found. No long-term mesh complications and/or interventions occurred. VAS scores were 0 (IQR: 0-2). Conclusions: Hernia repair with Phasix mesh in high-risk patients (VHWG 3, body mass index >28) demonstrated a recurrence rate of 15.9%, low pain scores, no mesh-related complications or reoperations for chronic pain between the 2- and 5-year follow-up. Four new recurrences occurred, 2 were asymptomatic. The poly-4-hydroxybutyrate mesh is a safe mesh for hernia repair in VHWG 3 patients, which avoids long-term mesh complications like pain and mesh infection.

Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair.

INTRODUCTION: Information on the long-term performance of biosynthetic meshes is scarce. This study analyses the performance of biosynthetic mesh (Phasix™) over 24 months. METHODS: A prospective, international European multi-center trial is described. Adult patients with a Ventral Hernia Working Group (VHWG) grade 3 incisional hernia larger than 10 cm2, scheduled for elective repair, were included. Biosynthetic mesh was placed in sublay position. Short-term outcomes included 3-month surgical site occurrences (SSO), and long-term outcomes comprised hernia recurrence, reoperation, and quality of life assessments until 24 months. RESULTS: Eighty-four patients were treated with biosynthetic mesh. Twenty-two patients (26.2%) developed 34 SSOs, of which 32 occurred within 3 months (primary endpoint). Eight patients (11.0%) developed a hernia recurrence. In 13 patients (15.5%), 14 reoperations took place, of which 6 were performed for hernia recurrence (42.9%), 3 for mesh infection (21.4%), and in 7 of which the mesh was explanted (50%). Compared to baseline, quality of life outcomes showed no significant difference after 24 months. Despite theoretical resorption, 10.7% of patients reported presence of mesh sensation in daily life 24 months after surgery. CONCLUSION: After 2 years of follow-up, hernia repair with biosynthetic mesh shows manageable SSO rates and favorable recurrence rates in VHWG grade 3 patients. No statistically significant improvement in quality of life or reduction of pain was observed. Few patients report lasting presence of mesh sensation. Results of biosynthetic mesh after longer periods of follow-up on recurrences and remodeling will provide further valuable information to make clear recommendations. TRIAL REGISTRATION: Registered on clinicaltrials.gov (NCT02720042), March 25, 2016.

Re-do surgery after prosthetic abdominal wall repair: intraoperative findings of mesh-related complications.

INTRODUCTION: Mesh repair is one of the most popular technique for the treatment of abdominal wall hernias, resulting in lower recurrence rates. However, it is associated with a high risk of mesh-related complications. The aim of the present study is to assess the impact of biomaterials on the intra-abdominal organs, in terms of adhesions and visceral complications, in a series of patients undergoing re-do surgery at our abdominal wall unit. MATERIALS AND METHODS: We reviewed the clinical records of 301 patients who undergone laparotomy between June 2008 and May 2018, selecting 67 patients with one or more previous prosthetic abdominal wall repair (AWR). RESULTS: The average number of previous repairs was 1.6 with a mean time interval of 66 months from the last repair. Clinical presentation included hernia recurrence (69%), mesh infection (26%), infection and recurrence (10%), and fistula (1%). Adhesions were intraoperatively observed in all patients, except for eight cases. Mesh was completely removed in 43 patients, partially in four. Postoperative complications were observed in 39% of cases, including wound dehiscence, hematoma, seroma, and mesh infection. CONCLUSIONS: Long-term implant results in abdominal wall repair and are not completely known, and literature is still lacking on this topic. Re-do surgery for subsequent pathological events may represent a way to increase our knowledge.

A new semiresorbable mesh for primary inguinal repair: a preliminary observational study on quality of life and safety.

BACKGROUND: A currently unsolved problem of open inguinal hernia repair (IHR) is chronic postoperative inguinal pain (CPIP), which affects 10-12% of patients after IHR. In the present paper, we explored the results of a newly designed partially absorbable mesh made of polypropylene and polylactic acid (HybridMesh®) for open hernia repair and its impact on postoperative safety, efficacy, comfort and pain. METHODS: A prospective multicentric pilot trial was conducted in third-referral centers across Italy (n = 5). Inclusion criteria were unilateral primary inguinal hernia in patients of both genders and BMI < 30 kg/m2. All patients were submitted to elective Lichtenstein mesh hernia repair under local anesthesia with HybridMesh. Primary outcome measure was the evaluation of Carolina Comfort Scale and modifications at 2 years after surgery and its correlation with surgical variables; secondary outcomes were postoperative early and late morbidity, recurrence and postoperative early quality of life. RESULTS: Between 2015 and 2016, 125 (5 female) patients were operated, 2-year follow-up rate was 100%. The surgical site occurrence rate was 28% without the need of procedural interventions. Twenty-four months after surgery, no case of severe CPIP was recorded and altered global CCS score was present in 16 patients (13.0%). At univariate analysis, CCS score was negatively affected by fixation with sutures (OR 3.949; 95% CI 1.334-13.300), with no effect shown on multivariate analysis. Alterations in pain and movement limitations domains of CCS were observed in 9.7% of patients, at univariate analysis; they occurred more frequently when the mesh was sutured (OR 4.437; 95% CI 1.387-17.025) and in patients suffering from SSO (ecchymosis: OR 3.269; 95% CI 1.032-10.405); however, no effect was shown on multivariate analysis. Two recurrences (1.6%) were identified within the first postoperative year. CONCLUSIONS: The results of this study support the safety, efficacy and good tolerability of HybridMesh as a device to treat primary unilateral inguinal hernia during open anterior approach. Further studies are needed to clarify its role in comparison to currently available devices at longer follow-ups.

Mesh-related visceral complications following inguinal hernia repair: an emerging topic.

The use of meshes in inguinal hernia repair (IHR) has gained popularity but new complications have been observed. Mesh-related visceral complications (MRVCs) are generally considered rare and hence are not studied in depth. We carried out a thorough literature search and collected 101 clinical reports published from 1992 to 2018. The reported complications seem to have tripled in the last decade. Ninety-seven cases met the inclusion criteria and they were subdivided into four groups (group A-onlay IHR, group B-3-D IHR, group C-preperitoneal IHR, group D-laparoscopic IHR) to be analyzed, according to the herniorraphy technique. Every prosthetic IHR can be followed by MRVCs but, according to the present review, the highest incidence is related to laparoscopic repairs, the lowest to Lichtenstein technique. Time-to-event was shorter in case of preperitoneal position of the prosthesis than when the mesh was implanted over the transversalis fascia. Urinary bladder involvement predominantly occurred after laparosopic IHR. A pathogenic correlation between the most frequently complained clinical signs and the previous mesh herniorraphy was rarely reported. The diagnosis was generally made at laparotomy, which was usually performed as an emergency. Removing the infected mesh and resecting or suture repairing the involved viscera was the challenging surgical treatment. Prevention of MRVCs after inguinal hernia repair appears to be an important significant issue. It is important to pay attention to the choice of a proper implantation site, avoiding direct contact between the mesh and viscera, and to select a proper device.

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 .

Adhesion prevention in ventral hernia repair: an experimental study comparing three lightweight porous meshes recommended for intraperitoneal use.

BACKGROUND: In ventral hernia repair, when prosthetic material is placed intraperitoneally, it may lead to an inflammatory reaction resulting in adhesions between the mesh and abdominal viscera. Several meshes have been developed to minimize this process. In this experimental study, the ability of different combined meshes to attenuate the adhesion formation was examined. METHODS: Three commercially available lightweight porous combined meshes were placed intraperitoneally to repair an abdominal wall defect in rats: DynaMesh-IPOM (PVDF + PP), TiMesh (titanium-coated filament PP) and C-QUR/FX (omega-3 fatty acid-coated filament PP). The DynaMesh-CICAT (PVDF) was implanted in the control group. Adhesion formation was macroscopically evaluated and scored after 7 and 21 days. RESULTS: All animals except two presented intra-abdominal adhesions. None of the meshes examined in the study demonstrated to prevent adhesions. C-QUR/FX reduced adhesion formation at 7 days' follow-up compared with all other meshes but by 21 days this effect was diminished. Between 7 and 21 days adhesion extension significantly decreased for TiMesh. TAS did not show significant modifications between 7 and 21 days' follow-up for each mesh. CONCLUSIONS: The combined porous meshes tested in the present study demonstrated to reduce but not to prevent the adhesion formation, even if with some differences. Combined porous meshes could be chosen instead of simple meshes for retro-rectus preperitoneal prosthetic ventral hernia repair.

The use of an acellular porcine dermal collagen implant in the repair of complex abdominal wall defects: a European multicentre retrospective study.

BACKGROUND: The use of biological materials for the repair of complex abdominal wall defects has increased over the years; however, the role of these materials in routine practice remains unclear. The aim of the study was to evaluate clinical outcomes following the use of Permacol™ porcine collagen surgical implant in complex abdominal wall repair. METHODS: This subset analysis of seven European sites from a multicentre retrospective study included patients undergoing open or laparoscopic surgery and treated with Permacol™ surgical implant. Inguinal, parastomal, diaphragmatic, perineal, and hiatal repairs were excluded. Only patients with at least 12 months of follow-up after surgery were included. RESULTS: A total of 109 patients (56 males and 53 females) were included. Patients had a median of two comorbidities (range 0-6). Thirty-three per cent of patients were treated for recurrent hernia. All but one case used an open approach. Sixty-six per cent were Center for Disease Control wound class II-IV at the time of surgery. Fascial closure was achieved in 69%. Median follow-up length was 720 days (range 368-2857). Recurrence rates at 1 and 2 years were 9.2 and 18.3 %, respectively, and were higher in cases without fascial closure. One-year recurrence was higher following use of an onlay technique (P = 0.025). In a multivariate analysis, among 16 comorbidities examined only fascial closure significantly impacted 1-year recurrence (P = 0.049). CONCLUSIONS: Data from this large retrospective multicentre European study strongly suggest the use of Permacol™ porcine collagen surgical implant to be safe and effective for complex abdominal wall repair. The recurrence rate was impacted by fascial closure.

Davide Fieschi: a pioneer of plug repair in groin hernia surgery.

Plug repair actually represents one of most recommended procedures in open groin hernia repair. It is generally recognized that Lichtenstein in 1968 first introduced the plug technique for femoral and recurrent inguinal hernia. The present paper backdates more than 50 years the first application of a plug due to an ingenious Italian surgeon named Davide Fieschi.

The Italian Register of Biological Prostheses.

BACKGROUND: A wide variety of meshes are available for surgical treatment of abdominal wall defects. These meshes are constructed with different materials with different biological properties. METHODS: A prospective database was instituted (January 2009-December 2010) to register biological prostheses (BPs) implanted in Italy. RESULTS: A total of 193 cases were registered. The mean age of the patients was 53.1 years (SD ±7.4). The ratio of males to females was 1.3 to 1. The mean body mass index was 28.2 (SD ±4.1). The breakdown of American Society of Anesthesiologists (ASA) scores was as follows: ASA I, 35.7%; ASA II, 27.5%; ASA III, 31.6%, and ASA IV, 5.2%. For ventral-incisional hernias, the mean duration of surgery was 101.1 min (SD ±25.3), while for inguinal-femoral hernias it was 49.2 min (SD ±19.1). The rate of urgent procedures was 36.7%. The surgical field was clean in 57.4% of cases, clean-contaminated in 21.3%, contaminated in 12.3% and dirty in 9%. Techniques used for inguinal-femoral hernias were as follows: Lichtenstein in 66.7%, plug and mesh in 3.8%, transabdominal-preperitoneal in 25.7% and intraperitoneal onlay mesh in 3.8%. The following prostheses were used: swine intestinal submucosa in 54.9%, porcine dermal collagen in 39.9% and bovine pericardium in 5.2%. In 45.1% of cases the prostheses were cross-linked. Techniques used for ventral-incisional hernias were as follows: onlay in 3.6%, inlay in 5.5%, sublay in 62.7% and underlay via laparoscopy in 28.2%. The mean overlap was 4.1 cm (SD ±1.2). No intestinal anastomosis was necessary in 65.3% of cases; however, small/large bowel resection and anastomoses were necessary in 22.3 and 12.4% of cases, respectively. Intraoperative blood transfusion was necessary in 10.4% of procedures. The skin was completely closed in 84% of procedures. At the 1-month follow-up, there were no complications in 54.4% of cases. Among the cases with complications, 10 patients (5.8%) experienced recurrence, and the postoperative readmission rate was 12.9%. The average visual analog scale (VAS) score for pain was 2.9 (SD ±1.2) at rest. At the 1-year follow-up, there were no complications in 96.4% of cases. Two patients experienced recurrence, and the postoperative readmission rate was 3.6%. The average VAS score for pain was 1.8 (SD ±0.8) at rest. CONCLUSIONS: This register shows that BPs are highly versatile and can be used in either open or laparoscopic surgery in all kinds of patients and in contaminated surgical fields. However, due to the very good outcomes of synthetic meshes and the high costs of BPs, the latter should only be used in selected cases.