Introduction Symptomatic neuroma with neuropathic pain can develop following peripheral nerve injury. Current interventions for symptomatic neuroma have unpredictable results. NEUROCAP (Polyganics, Groningen, The Netherlands) is a bioresorbable nerve capping device intended to protect a peripheral nerve end and separate the nerve from the surrounding environment, to prevent the recurrence of a symptomatic neuroma. Materials and Methods This study aims to assess the implantation effects of the NEUROCAP device in a rat sciatic nerve model during 12 months (±2 days). Forty-one adult male Sprague-Dawley rats were used in this study. They were randomly divided into a capping or test group, or a noncapping or control group for different time points of survival (12 weeks, 6 months, and 12 months). The objective of this study was evaluated regarding procedural data, adverse events, clinical observations, and histopathology. Results The overall general health of the animals was adequate throughout the study, with the exception of autotomy during the first 4 months of survival. Eight animals were euthanized early due to autotomy, excluded from the study and seven of them have been replaced. Autotomy was an expected outcome and a known limitation of the animal model, particularly as this was a full sciatic nerve transection model. Neuroma formation was observed in the control group while there was no neuroma formation present in the test group. The control group showed increased nerve outgrowth and more chaotic fascicles in comparison with the test group. The test group also had a higher percentage of myelinated fibers compared to the control group. These results indicate a preventive mode of action of the NEUROCAP with regard to neuroma formation after nerve transection in a rat sciatic nerve model. Conclusion The results indicate that NEUROCAP is safe and effective in preventing the recurrence of neuroma formation and inhibiting nerve outgrowth.
Background: Pancreatic ductal adenocarcinoma (PDAC) is associated with cachexia and reduced physical activity that is deteriorating further during neoadjuvant treatment. Systemic inflammation plays an important role in the host to cancer interactions associated with these conditions. The aim of this study is to assess the impact of an individual prehabilitation program, comprising of physical training and nutritional support on cachexia, physical fitness, quality of life (QoL) and inflammatory activity in patients with PDAC undergoing neoadjuvant treatment and to compare it with standard care. We hypothesize that pre-habilitation has the potential to preserve body composition, physical fitness and QoL during neoadjuvant treatment and improves perioperative outcome. Methods: Patients with borderline resectable or locally advanced PDAC scheduled for neoadjuvant treatment were assessed for participation and randomized to either a pre-habilitation program or standard care. The level of fitness, body composition and indicators of cachexia were assessed together with QoL and daily nutrient intake before and during neoadjuvant treatment as well as 1 month after surgery and compared between groups. Various modules of physical training and nutritional support were selected individually for each patient in the pre-habilitation group aiming to preserve physical fitness and body components as much as possible. Patients in the control group receive standard, symptom-based care without any specific pre-habilitation. Blood inflammatory activity was determined by C-reactive protein, IL-6, IL-1ra,IL-10, TNF-a and albumin together with neutrophil lymphocyte ratio, platelet lymphocyte ratio and Glasgow Prognostic Score. Perioperative outcome was determined by R0 resection rate, frequency of surgical complications according to Clavien-Dindo and length of hospital stay. Primary endpoint analysis between groups were con-ducted by paired samples t-test and Wilcoxon test for metric variables depending on the underlying distribution and McNemar test for categorical variables. For subgroup analysis Friedman test and analysis of variance were undertaken.
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