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Introduction: The incidence of incisional hernias (IHs) after open repair of an abdominal aortic aneurysm (AAA) is high. Several randomized controlled trials have reported favorable results with the use of prophylactic mesh to prevent IHs, without increasing complications. In this analysis, we report on the results of the 60-month follow-up of the PRIMAAT trial. Methods: In a prospective, multicenter, open-label, randomized design, patients were randomized between prophylactic retrorectus mesh reinforcement (mesh group), and primary closure of their midline laparotomy after open AAA repair (no-mesh group). This article reports on the results of clinical follow-up after 60 months. If performed, ultrasonography or computed tomography were used for the diagnosis of IHs. Results: Of the 120 randomized patients, 114 were included in the intention-to-treat analysis. Thirty-three patients in the no-mesh group (33/58-56.9%) and 34 patients in the mesh group (34/56-60.7%) were evaluated after 5 years. In each treatment arm, 10 patients died between the 24-month and 60-month follow-up. The cumulative incidence of IHs in the no-mesh group was 32.9% after 24 months and 49.2% after 60 months. No IHs were diagnosed in the mesh group. In the no-mesh group, 21.7% (5/23) underwent reoperation within 5 years due to an IH. Conclusions: Prophylactic retrorectus mesh reinforcement after midline laparotomy for the treatment of AAAs safely and effectively decreases the rate of IHs. The cumulative incidence of IHs after open AAA repair, when no mesh is used, continues to increase during the first 5 years after surgery, which leads to a substantial rate of hernia repairs.

Purpose: Abdominal wall hernia repair in contaminated cases remains a therapeutic challenge due to the high risk of post-operative surgical site occurrences (SSO). Slowly resorbable synthetic (biosynthetic) meshes have recently been introduced and may offer unique advantages when challenged with bacterial colonization during abdominal wall reconstruction. Methods: A multicenter single-arm retrospective observational cohort study examined all consecutive patients in whom a poly-4-hydroxybutyrate mesh (Phasix™ or Phasix™ ST; Becton Dickinson, Franklin Lakes, NJ, USA) was used for the repair of an inguinal or ventral/incisional hernia, or to replace an infected synthetic mesh. Patient records were analyzed according to the level of contamination, using the classification score of the Centers for Disease Control and Prevention (CDC). The primary objective was to evaluate short-term postoperative morbidity by assessing SSOs and the need for reoperation or even mesh excision. Results: A total of 47 patients were included. The median age was 68 years (30-87), the male/female ratio was 26/21, and the median BMI was 26.5 kg/m2 (16.4-46.8). There were 17 clean cases, 17 clean-contaminated, 6 contaminated and 7 dirty. Median follow-up time was 48 days. An SSO was seen in 4 clean (23.5%), 7 clean-contaminated (41.2%), 2 contaminated (33.3%) and 5 dirty cases (71.4%). A surgical site occurrence requiring procedural intervention (SSOPI) was seen in 2 clean (11.8%), 3 clean-contaminated (17.6%), 1 contaminated (16.7%) and 2 dirty cases (28.6%). Hernia recurrence was seen in 1 clean (5.9%), 2 clean-contaminated (11.8%) and 3 dirty cases (42.9%). Mesh excision had to be performed in only one case in the contaminated group. Conclusion: The Phasix™ mesh shows promising short-term results when used in contaminated hernia-related surgery. Even in contaminated or dirty conditions, with or without infection of the mesh, resection of the mesh only had to be performed once and patients could be managed either conservatively or by relatively minor reoperations. However, further research is needed to fully evaluate the safety and efficacy of these meshes.

BACKGROUND: Resorbable biomaterials have been developed to reduce the amount of foreign material remaining in the body after hernia repair over the long-term. However, on the short-term, these resorbable materials should render acceptable results with regard to complications, infections, and reoperations to be considered for repair. Additionally, the rate of resorption should not be any faster than collagen deposition and maturation; leading to early hernia recurrence. Therefore, the objective of this study was to collect data on the short-term performance of a new resorbable biosynthetic mesh (Phasix™) in patients requiring Ventral Hernia Working Group (VHWG) Grade 3 midline incisional hernia repair. MATERIALS AND METHODS: A prospective, multi-center, single-arm trial was conducted at surgical departments in 15 hospitals across Europe. Patients aged ≥18, scheduled to undergo elective Ventral Hernia Working Group Grade 3 hernia repair of a hernia larger than 10 cm2 were included. Hernia repair was performed with Phasix™ Mesh in sublay position when achievable. The primary outcome was the rate of surgical site occurrence (SSO), including infections, that required intervention until 3 months after repair. RESULTS: In total, 84 patients were treated with Phasix™ Mesh. Twenty-two patients (26.2%) developed 32 surgical site occurrences. These included 11 surgical site infections, 9 wound dehiscences, 7 seromas, 2 hematomas, 2 skin necroses, and 1 fistula. No significant differences in surgical site occurrence development were found between groups repaired with or without component separation technique, and between clean-contaminated or contaminated wound sites. At three months, there were no hernia recurrences. CONCLUSION: Phasix™ Mesh demonstrated acceptable postoperative surgical site occurrence rates in patients with a Ventral Hernia Working Group Grade 3 hernia. Longer follow-up is needed to evaluate the recurrence rate and the effects on quality of life. This study is ongoing through 24 months of follow-up. ispartof: INTERNATIONAL JOURNAL OF SURGERY vol:83 pages:31-36 ispartof: location:United States status: published

This retrospective study reveals the results of our approach to the treatment of complex ventral hernias. A single-center, single-surgeon retrospective chart review on 68 consecutive patients who underwent abdominal wall reconstruction for incisional herniation on the midline between January 2012 and December 2016 is presented. The Bonheiden technique is based on anterior component separation in combination with preperitoneal retromuscular mesh reinforcement of the midline. Data of 68 consecutive cases of incisional midline abdominal wall defects treated electively with the mesh reinforced anterior component separation technique were analyzed. Demographics, patient characteristics, and hernia properties were evaluated. Postoperative complications included 28% of wound infections/dehiscence, 25% seromas, and 7% hematomas. No recurrences have been seen. We conclude this technique to be safe and reliable for large midline defects in patients suffering with several comorbidities.

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 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).

Background:The incidence of incisional hernias after abdominal aortic aneurysm repair is high. Prophylactic mesh-augmented reinforcement during laparotomy closure has been proposed in patients at high risk of incisional hernia.Methods:A multicenter randomized trial was conducted on patients undergoing elective abdominal aortic aneurysm repair through a midline laparotomy (Clinical.Trials.gov: NCT00757133). In the study group, retromuscular mesh-augmented reinforcement was performed with a large-pore polypropylene mesh (Ultrapro, width 7.5cm). The primary endpoint was the incidence of incisional hernias at 2-year follow-up.Results:Between February 2009 and January 2013, 120 patients were recruited at 8 Belgian centers. Patients' characteristics at baseline were similar between groups. Operative and postoperative characteristics showed no difference in morbidity or mortality. The cumulative incidence of incisional hernias at 2-year follow-up after conventional closure was 28% (95% confidence interval [CI], 17%-41%) versus 0% (95% CI, 0%-6%) after mesh-augmented reinforcement (P < 0.0001; Fisher exact test). The estimated freedom of incisional hernia curves (Kaplan-Meier estimate) were significantly different across study arms ((2) = 19.5, P < 0.0001; Mantel-Cox test). No adverse effect related to mesh-augmented reinforcement was observed, apart from an increased mean time to close the abdominal wall for mesh-augmented reinforcement compared with the control group: 46 minutes (SD, 18.6) versus 30 minutes (SD, 18.5), respectively (P < 0.001; Mann-Whitney U test).Conclusions:Prophylactic retromuscular mesh-augmented reinforcement of a midline laparotomy in patients with abdominal aortic aneurysm is safe and effectively prevents the development of incisional hernia during 2 years, with an additional mean operative time of 16 minutes.

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 . ispartof: BMC SURGERY vol:18 issue:1 ispartof: location:England status: published

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(R)-mesh in laparoscopic ventral hernia repair. Patients and methods : During a 25 month period 210 adult patients underwent a laparoscopic primary or incisional hernia repair using an intra-abdominal placement of Proceed(R)-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.

Following our previous study about a lightweight self-adhering mesh (Adhesix®, Cousin Biotech, Wervicq-Sud, France; distributed by Davol Inc., subsidiary of C.R. Bard, Inc.), we report the long-term results with the use of this mesh in patients treated for a primary, unilateral inguinal hernia without any other hernias. Prospectively collected data of 100 patients between February 2011 and February 2014 were analyzed. The mean follow-up time was 2.7 years (range 1-4), and mean length of hospital stay was 0.6 days (range 0.5-1). At the time of the last follow-up visit, two patients (2%) had a recurrent inguinal hernia. Compared to preoperative values, patients reported a significant reduction in their pain sensation (visual analogue scale, VAS) after one month (4.61 vs. 1.32; P0.001). A difference in VAS scores remained significant at the last follow-up visit (1.31 vs. 0.28; P0.001). Patients reported high quality of life scores. Only one patient (1%) developed a clinically significant seroma that required an evacuating puncture. Two patients (2%) had superficial wound infections. Neither mesh infections nor mortalities occurred. This study, with a long follow-up, confirms our previous results: use of the Adhesix® mesh is safe, feasible, and efficient in laparoscopic hernia repair.

The Ultrapro® Advanced™ mesh (Ethicon, Sommerville, NJ) is a new mesh design, using the best characteristics from the previous platform, while adding new, advanced features. Our centre, Imelda Hospital, Bonheiden, Belgium, was chosen as one of the first clinical testing sites. The aim of this study was to present our preliminary data on complication rate and patient satisfaction.From October 1, 2015 until January 31, 2016, we treated 57 patients, implementing 67 Ultrapro® Advanced™ meshes. One patient was excluded due to postoperative cerebral haemorrhage with aphasia. Only patients with more than one-month follow-up were included for further analysis, resulting in a population of 41 patients with 51 meshes. Of them, 35 were male and only 6 were female, with an average age of 61.4 years and an average BMI of 25.9. The indications were uni- and bilateral laparoscopic inguinal hernia repair (n = 23 and 10 respectively), open inguinal hernia repair (n = 3), and open incisional hernia repair (n = 5). Quality of life was measured preoperatively and at four weeks postoperatively, using the hernia specific Carolina Comfort Scale (CCS) questionnaire.The primary endpoint was complication rate. Only two patients (4.8%) mentioned a mild scrotal hematoma and two patients (4.8%) demonstrated a seroma. There were no superficial wound infections nor early recurrent hernias. Our secondary endpoint was quality of life, measured by the CCS questionnaire, which differentiates between a symptomatic and an asymptomatic group. A total of 13 patients were asymptomatic, whilst 28 patients reported some sort of discomfort, ranging from mild (n = 25) to moderate and/or daily symptoms (n = 3). No patients were disabled by their symptoms.The Ultrapro® Advanced™ is a sequel of the classic Ultrapro® mesh with similar characteristics: it is a "lightweight", macroporous, partially absorbable mesh built out of thin filaments, while maintaining sufficient strength. Its improvement is due to incorporation of evidence-based characteristics such as an increased mesh elasticity. Furthermore, the surgical manipulation is improved thanks to the increased mesh memory. Our prospective cohort study shows good initial and short-term results after implementation of the Ultrapro® Advanced™. However, further prospective research is mandatory on the long-term outcomes.

Laparoscopic ventral hernia repair (LVHR) is a common procedure in abdominal surgery. Use of mesh has become the gold standard in the last decade because of significantly fewer recurrences. Subsequently, the attention shifted to reduce mesh related complications in the short- and long-term as well as to facilitate its handling and positioning. In continuation of our previous study, we conducted a final analysis about the use of the Ventralight™ ST hernia patch (Davol Inc, Subsidary of C. R. Bard, Inc. Warwick, RI).Prospectively collected data of 61 consecutive patients (men/women: 44/17) from July 2011 to October 2013 were analysed in this final study. Patients were evaluated clinically at four time points in total. At the final clinical check- up, 97% of the total study population was reassessed. The primary outcome parameter was recurrence. Secondary outcome parameters were described in terms of mesh related complications, pain scores, and quality of life.Mean follow-up time was 23 months (range 16-44). Mean length of hospital stay was four days (range 2-17). There were no operative complications. Two patients (both80 years old) died more than one year after the procedure because of a cardiovascular event. One morbidly obese patient (2%) treated for a recurrent incisional hernia showed a second recurrence at the last follow-up visit. A clinical significant seroma was observed in two patients (3%) one month postoperatively. At last follow-up, two patients (3%) reported persistent mild discomfort at one specific spot. There was a significant reduction in the visual analogue scale (VAS) scores at the last follow-up visit compared to preoperative scores (3.01 vs. 0.27; P0.01). Quality of life measurements using the SF-36 questionnaire showed good results.This final analysis of long-term follow-up results on the use of the Ventralight™ ST hernia patch in laparoscopic ventral hernia repair confirms our preliminary findings of the previous two reports. Use of the Ventralight™ ST hernia patch is associated with good short- and long-term outcomes and can be considered as safe and feasible in LVHR.

The purpose of this study was to show the short- and long-term results of a lightweight self-adhering mesh, Adhesix®. Between February 2011 and April 2013, we prospectively collected data of 100 consecutive patients who underwent incisional or inguinal hernia repair. Mean follow-up time was 23 months (range 7-33 months). Mean length of hospital stay was 1.7 days (range 0.5-16 days). No recurrences occurred. Pain was significantly reduced after 1 month (4.1 vs 1.6; 95% confidence interval [CI] 1.9-3.1; P0.0001) as well as at the last follow-up visit (1.6 vs 0.48; 95% CI 0.6-1.7; P0.0001). SF 36 scaled scores, as an indicator of quality of life, were good with 86, 84, 86, 84, 83, 88, 92, 87. Only 2 patients developed clinically significant seromas. No clinically significant hematomas were observed. Neither mesh nor wound infections occurred. Four patients developed urinary retention immediately postoperative, while 2 were hospitalized 2 weeks after discharge because of pneumonia. Two patients died because of unrelated causes. Based on these results, use of the Adhesix mesh seems to be safe, feasible, and efficient in hernia repair.

The purpose of the current prospective study was to confirm the results of our previous study on the use of the Ventralight™ ST mesh. In this study we also evaluated a pre-attached positioning system. Between July 2011 and October 2013 prospectively collected data of 61 consecutive patients who underwent a laparoscopic ventral hernia repair were analyzed. Short- and long-term outcomes were described. A total of 61 patients were treated in this period (men/women ratio 44/17). Overall median follow-up was 7 months (range 2-29). There were 30 patients with a follow-up of at least 12 months. Mean hernia diameter was 6 x 5 cm (craniocaudal x laterolateral) (range 1.5 x 1.5 to 20 x 15 cm). Overall mean length of hospital stay was 4.4 days. Postoperative visual analog scale (VAS) at last follow-up was significantly lower than the preoperative VAS (3.01 vs 0.68; P = 0.011) There were no intraoperative complications. In the whole group, only 6 patients (10%) showed minor complications. Four patients had mild discomfort, another 2 patients developed a clinically significant seroma. The complication rate in the subgroup with a follow-up of at least 1 year was 13%. No recurrences were observed. This study confirms our preliminary findings on the use of this mesh. The optional positioning system offers a significantly more quick and proper mesh positioning.

The aim of the current prospective study was to show the results of a new type of medium-weight monofilament polypropylene mesh covered with a hydrogel barrier on the visceral side. Between July 2011 and April 2013 prospectively collected data on 30 consecutive patients who underwent abdominal wall hernia repair using a medium-weight mesh covered with carboxymethylcellulose-sodiumhyaluronate coating (Ventralight™ ST mesh, Davol Inc, Subsidary of C. R. Bard, Inc. Warwick, RI) were analyzed. Out of these patients, those who had a follow-up of at least 12 months were selected. Short- and long-term outcomes were described. Meanwhile, registration continues up to completion of a series with 100 included patients. A total of 17 patients were selected (men/women ratio 11/6). Median follow-up was 12 months (range 12-21). Mean hernia diameter was 7 cm x 5 cm (craniocaudal x laterolateral) (range 1.5 x 1.5 to 20 x 15). Mean length of hospital stay was 6.1 days. Postoperative Visual Analogue Scale (VAS) at last follow-up was significantly lower than the preoperative VAS (P = 0.017) There were no intraoperative complications. Four patients (23%) developed minor complications. Two patients had mild discomfort, another two patients developed a seroma. No recurrences were observed. This intermediate study shows good results using a biofilm coated mesh and confirm the positive results obtained in the Sasse clinical trial.

The ideal mesh suited for intraperitoneal placement should address both requirements of tissue separation on the visceral surface and tissue integration on the parietal surface. Meshes with bioresorbable coatings have recently been demonstrated to be successful. In this article, the results are shown of a study with a new type of tissue-separating lightweight mesh with a bioresorbable coating (Physiomesh; Ethicon, Somerville, NJ) in laparoscopic ventral hernia repair. In this single-center retrospective analysis, 88 patients (50 men, 38 women) undergoing hernia surgery between November 16, 2010 and August 10, 2012 at the Imelda Hospital Bonheiden were included. Patients were asked to score their pre- and postoperative pain (1 month after surgery) on a visual analogue scale (VAS), as well as the chronic postoperative pain (pain at more than 6 months after surgery). The time period after which patients were pain free and after which they could return to work was also noted. Our results demonstrate that Physiomesh is a good alternative to the existing meshes leading to significant pain reduction, early return to work, acceptable complications, and low recurrence and reintervention rates.

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.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.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.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.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.

Surgical treatment of umbilical and small ventral hernias ranges from a simple suture repair to the placement of large intra-abdominal or retromuscular meshes. Several articles report a lower incidence of recurrence after mesh repair, whether this is positioned onlay, retromuscular, or intraperitoneally. Often, a simple suture repair fails in the longterm, whereas a laparoscopic or retromomuscular approach seems too extensive for these rather small hernias. In between those two treatment options exists a go-between repair that carries the idea of posterior repair without being so aggressive in its approach. In this study, the authors examined a new device called the Proceed Ventral Patch (PVP) (Ethicon, Inc., Sommerville, NJ, USA). It is a self-expanding, partially absorbable, flexible laminate mesh device that allows an easy, quick and minimal invasive, tension-free, and standardized approach to umbilical hernia treatment. No data nor publication exist on this new device. Reported herein is our early and first experience with this novel technique.

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., Comparative Study, Consensus Development Conference, Journal Article, Review, SCOPUS: ar.j, info:eu-repo/semantics/published