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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: 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.
Background: Low anterior resection (LAR) is often performed with diverting loop ileostomy (DLI) for anastomotic protection in patients with rectal cancer. We aim to analyze, if older patients are more prone to a decline in kidney function following creation and closure of DLI after LAR for rectal carcinoma versus younger patients.
Methods: A retrospective cohort study from a database including 151 patients undergoing LAR for rectal carcinoma with DLI was used. Patients were divided in two age groups (Group A: <65 years, n = 79; Group B: ≥65 years, n = 72). For 123 patients undergoing DLI reversal prognostic factors for an impairment of serum creatinine (SCr) and estimated glomerular filtration rate (eGFR) 3 months after DLI reversal was analyzed using a multivariate linear regression analysis.
Results: SCr before LAR(T0) was significant higher in Group B (P = 0.04). Accordingly, the eGFR at T0 in group B was significantly lower (P < 0.001). No patients need to undergo hemodialysis after LAR or DLI reversal.
Age and SCr at T0were able to statistically significant predict an increase in SCr (P<0.001) and eGFR (P=0.001) three months after DLI reversal (The R2 for the overall model was .82 (adjusted R2 = .68).
Conclusion: DLI creation may result in a reduction of eGFR in older patients 3 months after DLI closure. Apart from this, patients do not have a higher morbidity after creation and closure of DLI resulting from LAR regardless of their age.
Einleitung: Die Behandlung stumpfer abdomineller Verletzungen hat sich innerhalb der letzten Jahre zugunsten der konservativen Therapie gewandelt. Die Untersuchung beschäftigt sich mit der Frage, ob nichtoperatives Management von Abdominalverletzungen eine sichere und in der Routine praktikable therapeutische Option darstellt und wie häufig eine Konversion von primär konservativen zu operativen Management durchgeführt werden muß. Methodik: In einem Zeitraum von 3 Jahren (September 2002 bis August 2005) wurden 1214 Patienten über den Schockraum der Uniklinik Frankfurt aufgenommen. Die Datenerhebung und der Behandlungsverlauf erfolgte prospektiv on-line über den gesamten Behandlungsverlauf mittels des on-line Dokumentationsprogrammes Traumawatch´. Ergebnisse: Der durchschnittliche ISS aller Patienten lag bei 15. Eine relevante abdominelle Beteiligung (AIS >3) bestand in 12,4% der Fälle (151 Patienten) mit einem mittleren ISS von 33. Es wurden 60 Leberverletzungen (39,7%), 50 Milzverletzungen (33,1%), Verletzungen des Darms und Mesenterium in 19 Fällen (12,6%), 15 Verletzungen der Niere und der Harnwege(9,9 %) und Verletzungen Bauchdecke bei 28 Patienten (18,5 %) festgestellt. Das Pankreas war bei 3 Patienten (2,0%) und das Zwerchfell bei 8 Patienten (5,3%) betroffen. In 77 Fällen (51%) wurden die Patienten mit Abdominaltrauma primär konservativ, in 74 Fällen (49%) operativ versorgt, 10 Patienten (7%) wurden laparoskopiert. Nur bei 2 Patienten (1,3%) musste eine Konversion von der primär konservativen Therapie in eine operative erfolgen. Es handelte sich hierbei um eine sekundäre Darmperforation und eine zweizeitige Milzruptur. Patienten mit einer Leberverletzung konnten in 65% der Fälle konservativ versorgt werden, Patienten mit Milzverletzung hingegen nur in 50% der Fälle. 32% der operierten Patienten wurden splenektomiert. 4 Patienten, alle mit einem AIS-Abdomen größer oder gleich 4, verstarben im Schockraum noch vor operativer Interventionsmöglichkeit. Schlussfolgerung: Nichtoperatives Vorgehen beim Polytrauma mit abdomineller Beteiligung ist bei hämodynamisch stabilem Patienten weitgehend sicher möglich. Insbesondere für Leberverletzungen bis einem Schweregrad Moore V stellt das primär konservatives Vorgehen eine geeignete therapeutische Option dar.