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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.

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 lif

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.

Background: Prophylactic mesh-augmented reinforcement during closure of abdominal wall incisions has been proposed in patients with increased risk for development of incisional hernias (IHs). As part of the BioMesh consensus project, a systematic literature review has been performed to detect those studies where MAR was performed with a non-permanent absorbable mesh (biological or biosynthetic). Methods: A computerized search was performed within 12 databases (Embase, Medline, Web-of-Science, Scopus, Cochrane, CINAHL, Pubmed publisher, Lilacs, Scielo, ScienceDirect, ProQuest, Google Scholar) with appropriate search terms. Qualitative evaluation was performed using the MINORS score for cohort studies and the Jadad score for randomized clinical trials (RCTs). Results: For midline laparotomy incisions and stoma reversal wounds, two RCTs, two case–control studies, and two case series were identified. The studies were very heterogeneous in terms of mesh configuration (cross linked versus non-cross linked), mesh position (intraperitoneal versus retro-muscular versus onlay), surgical indication (gastric bypass versus aortic aneurysm), outcome results (effective versus non-effective). After qualitative assessment, we have to conclude that the level of evidence on the efficacy and safety of biological meshes for prevention of IHs is very low. No comparative studies were found comparing biological mesh with synthetic non-absorbable meshes for the prevention of IHs. Conclusion: There is no evidence supporting the use of non-permanent absorbable mesh (biological or biosynthetic) for prevention of IHs when closing a laparotomy in high-risk patients or in stoma reversal wounds. There is no evidence that a non-permanent absorbable mesh should be preferred to synthetic non-absorbable mesh, both in clean or clean-contaminated surgery.

Meeting Abstract : Deutsche Gesellschaft für Chirurgie. 125. Kongress der Deutschen Gesellschaft für Chirurgie. Berlin, 22.-25.04.2008 Einleitung: Konventionelle Ösophagusresektionen gehen auch heute noch mit einer hohe Morbidität und Mortalität einher. Die Ergebnisse einiger Serien minimal-invasiver Ösophagusresektionen sind vielversprechend, aber kontrovers diskutiert. Material und Methoden: Im Rahmen einer Beobachtungsstudie werden seit Mai 2005 minimal-invasive thorakoabdominelle Ösophagektomien mit cervikalem Magenhochzug durchgeführt. Die operativen Parameter und der postoperative Verlauf werden prospektiv erfasst und jetzt retrospektiv ausgewertet. Ergebnisse: Seit Mai 2005 wurden 28 Patienten minimal-invasive ösophagektomiert, 3 transhiatal und 25 thorakoabdominell. Indikation waren Plattenepithelkarzinome bei 14 und distale Adenokarzinome bei 13 Patienten, bei einem Patienten eine langstreckige benigne Stenose. Die Tumorstadien waren UICC-IIa in 7, UICC-2b in 2 und UICC-III in 18 Patienten. 11 Patienten (41%) wurden neoadjuvant vorbehandelt. Die OP-Zeit betrug im Mittel 296 Min. +/- 46 Min., der intraoperative Blutverlust 110 ml +/- 131 ml. Ein abdomineller Operationsabschnitt wurde konvertiert (4%), thorakal war bisher keine Konversion notwendig. R-0 Resektionen wurde in 26/27 Patienten (96%) erzielt, die mittlere Anzahl entfernter Lymphknoten betrug 19. Die 30-Tage –Letalität war 0, die Krankenhausletalität 11%. Die Morbidität betrug 54% und beinhaltet 7 Anastomoseninsuffizienzen, 2 „Ösophago“-tracheale Fisteln, 1 Hiatushernie, 2 Recurrensparesen, 2 Pneumonien und 1 beatmungspflichtiges Delir. Drei Patienten (11%) wurden operativ revidiert (eine Fistel, eine Anastomoseninsuffizienz bei Magenschlauchnekrose, eine Hiatushernie). Schlussfolgerung: Nach Einführung der minimal-invasiven thorakoabdominellen Ösophagektomie werden die exzellenten Ergebnisse anderer minimal-invasiver Serien bisher nicht erreicht, entsprechen aber im Wesentlichen den Ergebnissen de

Einleitung: Obwohl laparoskopische, resezierende Verfahren am Magen als atypische Wedge-Resektionen weitgehend etabliert sind, werden formale Magenresektionen eher selten laparoskopisch durchgeführt. Die Gründe sind die Komplexität formaler, laparoskopischer Magenresektionen und die Seltenheit geeigneter Indikationen. Das Video zeigt eine Gastrektomie bei einem pT2a Magenkarzinom. Material und Methoden: Die Operation erfolgt in „Liegestuhl-Lagerung“. Die Trokarplatzierung entspricht weitgehend der einer Fundoplikatio. Zunächst wird das Omentum majus vom Colon transversum abgelöst und die große Kurvatur und der Fundus mittels Ultraschalldissektion mobilisiert. Nach Lösen der retrogastralen Verklebungen wird das postpylorische Duodenum mobilisiert und mit dem GIA abgesetzt. Die Lymphadenektomie im Lig. Hepatoduodenale erfolgt von lateral nach medial, wobei die A.gastrica dexter abgesetzt wird. Lymphadenektomie kranial deer Al lienalis und radikuläres Absetzen der A.gastrica sin. Nach Mobilisierung des distalen Ösophagus offenes Absetzen desselben und Einküpfen eine 25mm Andruckplatte. Durchtrennen des Jejunums und Mesojejunums ca. 40 cm aboral von Treitz. Der Zirkularstapler wird durch eine Erweiterung der Trokarinzision im linken Oberbauch eingeführt und dann laparoskopisch die Krückstock-Anastomose gestaplet. Der Krückstock wird mit dem Linearstapler verschlossen und die Dichtigkeit mittels Methylenblauinstillation geprüft. Dann wird die erweiterte Trokarinzision zur Minilaparotomie erweitert und das Resektat geborgen, die Y-Roux-Anastomose erfolgt offen durch die Mini-Laparotomie. Ergebnisse: Die OP-Zeit der gezeigten OP betrug 270 min., der intraoperative Blutverlust 40 ml. Der postoperative Verlauf war komplikationslos, die postoperative Verweildauer betrug 8 Tage. Histologisch zeigte sich ein Siegelringkarzinom des Magens pT2a, pN0 (0/21) M0 G3 R0. Schlussfolgerung: Das Video demonstriert, dass die laparoskopische Gastrektomie mit guter Übersicht sicher durchfüh