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 (TM) 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 1.8cm (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 24months. 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 24months 0 [0-6] (P<0.001). 99% (102/103) of the patients were satisfied with their repair at 24months 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)

Classification of primary and incisional abdominal wall hernias

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 StudyConsensus Development ConferenceJournal ArticleReviewSCOPUS: ar.jinfo:eu-repo/semantics/publishe

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

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

PREVENTION OF INCISIONAL HERNIA AFTER MIDLINE LAPAROTOMY FOR ABDOMINAL AORTIC ANEURYSM TREATMENT: A RANDOMIZED CONTROLLED TRIAL

Background: The incidence of incisional hernias (IH) after open abdominal aortic aneurysm (AAA) repair is high. Prophylactic mesh augmentation (PMA) during laparotomy closure has been proposed in high-risk patients. Methods: A multicenter prospective randomized controlled study was conducted on patients undergoing elective repair of AAA through midline laparotomy (Clinical.Trials.gov: NCT00757133). In the study group a retro-muscular PMA was performed with a large-pore polypropylene mesh (Ultrapro™, width 7.5 cm). The primary endpoint was the incidence of IH at 24 months. Results: Between February 2009 and January 2013, 120 patients were recruited at 8 Belgian centers. Patients' characteristics at baseline were similar between the groups. Operative and postoperative characteristics showed no difference in morbidity or mortality. A highly significant reduction of IH incidence was found after PMA compared to conventional closure, respectively 0% (CI: 0 % - 5.5%) versus 27.6% (CI: 16.7% - 40.9%) (P<0.0001; Fisher's exact test). The estimated "freedom of IH" curves (Kaplan-Meier estimate) were significantly different across study arms (X2=18.93, P<0.0001; Mantel-Cox test). No adverse effects were observed, apart from an increased mean (SD) time to close the abdominal wall for PMA: 46.2 min (18.6) versus 29.6 min (18.5) (P<0.001; Mann-Whitney U test). Conclusion: Prophylactic retro-muscular mesh augmentation of a midline laparotomy in AAA patients is safe and effectively prevents the development of IH, with an extra time investment of 17 minutes

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(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

Avaliação de morbidade em pacientes da UTI pediátrica : resultados preliminares

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Avaliação de morbidade em pacientes da UTI pediátrica do HCPA : resultados preliminares

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