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.

Primary non-complicated midline ventral hernia: is laparoscopic IPOM still a reasonable approach?

PURPOSE: Ventral hernia repair has become a common procedure, but the way in which it is performed still depends on surgeon's skill, experience, and habit. The initial open approach is faced with extensive dissection and a high risk of infection and prolonged hospital stay. To tackle these problems, minimally invasive procedures are gaining interest. Several new techniques are emerging, but laparoscopic intra-peritoneal onlay mesh (IPOM) is still the mainstay for many surgeons. We will discuss why laparoscopic IPOM is still a valuable approach in the treatment of primary non-complicated midline hernias and review the current literature. METHODS: We performed a literature search across PubMed and MEDLINE using the following search terms: "Laparoscopic hernia repair", "Ventral hernia repair" and "Primary ventral hernia". Articles corresponding to these search terms were individually reviewed by the primary author and selected on relevance. CONCLUSION: Laparoscopic IPOM still is a good approach for the efficient treatment of primary non-complicated midline hernias. Several techniques are emerging, but are faced with increased costs, technical difficulties, and low study patient volume. Further research is warranted to show superiority and applicability of these new techniques over laparoscopic IPOM, but until then laparoscopic IPOM should remain the go-to technique.

Open ventral hernia repair with a composite ventral patch - final results of a multicenter prospective study.

BACKGROUND: This study assessed clinical outcomes, including safety and recurrence, from the two-year follow-up of patients who underwent open ventral primary hernia repair with the use of the Parietex™ Composite Ventral Patch (PCO-VP). METHODS: A prospective single-arm, multicenter study of 126 patients undergoing open ventral hernia repair for umbilical and epigastric hernias with the PCO-VP was performed. RESULTS: One hundred twenty-six subjects (110 with umbilical hernia and 16 with epigastric hernia) with a mean hernia diameter of 1.8 cm (0.4-4.0) were treated with PCO-VP. One hundred subjects completed the two-year study. Cumulative hernia recurrence was 3.0% (3/101; 95%CI: 0.0-6.3%) within 24 months. Median Numeric Rating Scale pain scores improved from 2 [0-10] at baseline to 0 [0-3] at 1 month (P < 0.001) and remained low at 24 months 0 [0-6] (P < 0.001). 99% (102/103) of the patients were satisfied with their repair at 24 months postoperative. CONCLUSIONS: The use of PCO-VP to repair primary umbilical and epigastric defects yielded a low recurrence rate, low postoperative and chronic pain, and high satisfaction ratings, confirming that PCO-VP is effective for small ventral hernia repair in the two-year term after implantation. TRIAL REGISTRATION: The study was registered publically at clinicaltrials.gov ( NCT01848184 registered May 7, 2013).

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 .

A belgian multicenter prospective observational cohort study shows safe and efficient use of a composite mesh with incorporated oxidized regenerated cellulose in laparoscopic ventral hernia repair.

BACKGROUND: A variety of anti-adhesive composite mesh products have become available to use inside the peritoneal cavity. However, reimbursement of these meshes by the Belgian Governemental Health Agency (RIZIV/INAMI) can only be obtained after conducting a prospective study with at least one year of clinical follow-up. This -Belgian multicentric cohort study evaluated the experience with the use of Proceed®-mesh in laparoscopic ventral hernia repair. METHODS: During a 25 month period 210 adult patients underwent a laparoscopic primary or incisional hernia repair using an intra-abdominal placement of Proceed®-mesh. According to RIZIV/INAMI criteria recurrence rate after 1 year was the primary objective, while postoperative morbidity, including seroma formation, wound and mesh infections, quality of life and recurrences after 2 years were evaluated as secondary endpoints (NCT00572962). RESULTS: In total 97 primary ventral and 103 incisional hernias were repaired, of which 28 (13%) were recurrent. There were no conversions to open repair, no enterotomies, no mesh infections and no mortality. One year cumulative follow-up showed 10 recurrences (n = 192, 5.2%) and chronic discomfort or pain in 4.7% of the patients. Quality of life could not be analyzed due to incomplete data set. CONCLUSIONS: More than 5 years after introduction of this mesh to the market, this prospective multicentric study documents a favorable experience with the Proceed mesh in laparoscopic ventral hernia repair. However, it remains to be discussed whether reimbursement of these meshes in Belgium should be limited to the current strict criteria and therefore can only be obtained after at least 3-4 years of clinical data gathering and necessary follow-up.

Retrospective analysis of umbilical, epigastric, and small incisional hernia repair using the Ventralex™ hernia patch.

OBJECTIVE: The aim of this retrospective study was to determine the long-term recurrence and complication rates following small abdominal wall hernia repair with the Ventralex hernia patch. The study also aimed to identify risk factors for hernia recurrence in patients undergoing such repair and to examine the relationship between quality of life and hernia recurrence. BACKGROUND: Hernia repair using prosthetic mesh materials has become the preferred method of repair, as the recurrence rates are much lower than with conventional repair techniques. The prevention of long-term complications and improvements in the quality of life should also be considered as important features of successful repair. The Ventralex patch is a bilayer prosthesis, designed for retromuscular or intraperitoneal placement. Currently, seven studies have evaluated the device for small ventral hernia repair, and all have shown low short- and long-term recurrence rates. MATERIALS AND METHODS: The medical records of 176 patients who underwent abdominal wall hernia repair using the Ventralex patch between May 2004 and February 2009 were reviewed. All patients were followed up after 1 month and later in 2010. The rate of recurrence, immediate postoperative and long-term complications, and quality of life were evaluated. RESULTS: Long-term follow-up data were available for 135 patients. The mean follow-up was 49 months (range 13-70 months). There were 12 hernia recurrences (8.9%) during this time. Postoperative (1-month) complications included seroma (4%), superficial surgical site infections (3%), and an abscess (1.5%). At the mean long-term follow-up, complications included infection (1.5%) and subobstruction (1.5%). The only risk factor for hernia recurrence was female gender (unadjusted odds ratio 0.19, 95% confidence interval [CI] 0.05-0.72, P = 0.02). Patients with hernia recurrence reported significantly lower quality of life scores than patients without recurrence. CONCLUSIONS: The Ventralex hernia patch offers a simple and quick means of repairing small abdominal wall hernias. A relatively high recurrence rate was observed in this study. Reviewing the available literature, a critical appraisal is needed, attention should be paid to follow the correct implantation technique, proper deployment technology should be used, and a lightweight version would be welcome.

A true ectopic, locally vascularized spleen: a very rare anomaly.

In contrast to a wandering or ectopic spleen which is vascularized by the original splenic vessels this case describes a true ectopic, locally vascularized spleen in the pelvis. To our knowledge this anomaly has never been described in the literature before.

Classification of primary and incisional abdominal wall hernias.

PURPOSE: A classification for primary and incisional abdominal wall hernias is needed to allow comparison of publications and future studies on these hernias. It is important to know whether the populations described in different studies are comparable. METHODS: Several members of the EHS board and some invitees gathered for 2 days to discuss the development of an EHS classification for primary and incisional abdominal wall hernias. RESULTS: To distinguish primary and incisional abdominal wall hernias, a separate classification based on localisation and size as the major risk factors was proposed. Further data are needed to define the optimal size variable for classification of incisional hernias in order to distinguish subgroups with differences in outcome. CONCLUSIONS: A classification for primary abdominal wall hernias and a division into subgroups for incisional abdominal wall hernias, concerning the localisation of the hernia, was formulated.