18 research outputs found

    Prosthetic strap system for simplified ventral hernia repair. Its results in a porcine experimental model.

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    Abstract: Introduction Aiming to achieve a simplified ventral hernia repair, a proprietary shaped mesh was experimentally tested in the porcine model. The mesh is structured with a large central body and radiating straps. The friction of the straps passing through the tissues are hypothesized to be adequate to maintain the mesh in place during tissue ingrowth, avoiding classic point fixation while ensuring a wide coverage of the abdomen. Methods The mesh, having 6 radial straps, was placed using a sublay preperitoneal technique in 4 pigs. All straps were passed laterally through the abdominal wall and exteriorized from the skin. The straps were trimmed at the level of the skin, allowing the stumps to recoil into the subcutaneous space. The animal were euthanized at 1 and 4 months to determine the integration of the straps. Results Macroscopically all 24 straps were firmly incorporated within the abdominal wall. The tension free placement of the mesh by using the straps was effective. The friction of the straps passing through the tissues was adequate to keep the mesh well orientated. No dislocation of the implants was observed. The strap system also allowed a broader coverage of the abdominal wall, far beyond the wound opening. Conclusions The described arm system of the described implant seems to be effective in eliminating point fixation of the mesh. The fixation arms seemed to have ensured the mesh stayed orientated in all animals. A very wide lateral mesh placement was accomplished, assuring sufficient defect overlap when shrinkage occurs

    Vacuum inversion and securing of distal colonic pseudodiverticula with novel spiked O-rings

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    Diverticular disease is increasingly prevalent in Western societies and is associated with significant morbidity. OBJECTIVE: Two-stage endoscopic device development for inversion and secured ligation of colonic diverticula; first, human cadaver studies were performed to measure forces required for diverticular inversion; second, a novel set of devices (elastic spiked O-ring with delivery system) was tested in animals. DESIGN: Prospective, observational study of human cadavers and prospective, interventional study of a porcine model. SETTING: University hospital pathology laboratory and animal facility. INTERVENTION: Full-thickness inversion of the colonic wall with a pipelike delivery instrument to produce an inverted pseudodiverticulum that was secured with a spiked O-ring. MAIN OUTCOME MEASUREMENTS: The forces required for diverticular inversion, the secured closure of inverted pseudodiverticula, and the time until necrotic tissue falls off. RESULTS: A total of 248 of 248 of cadaveric sigmoid diverticula could be inverted by means of vacuum or forceps. The forces required for inversion ranged from 0.28 to 0.47 N (median, 0.37 N). Twenty-four spiked O-rings were delivered in 6 living pigs to produce 24 inverted pseudodiverticula. One animal died the day after the procedure of a pulmonary thromboembolism. In the remaining 5 pigs, all delivered spiked O-rings remained in place for 7 to 22 days. At necropsy, none of the inverted sites showed signs of perforation but rather full-thickness reparative scarring with ingrowth of connective tissue. LIMITATIONS: Animal model, stiff pipelike delivery instrument, variations in diverticular location, diameter, and size. CONCLUSIONS: Endoluminal inversion and securing of colonic diverticula induces tissue necrosis, diverticular sloughing, and full-thickness scarring

    Polybutylene succinate artificial scaffold for peripheral nerve regeneration

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    Regeneration and recovery of nerve tissues are a great challenge for medicine, and positively affect the quality of life of patients. The development of tissue engineering offers a new approach to the problem with the creation of multifunctional artificial scaffolds that act on various levels in the damaged tissue, providing physical and biochemical support for the growth of nerve cells. In this study, the effects of the use of a tubular scaffold made of polybutylene succinate (PBS), surgically positioned at the level of a sciatic nerve injured in rat, between the proximal stump and the distal one, was investigated. Scaffolds characterization was carried out by scanning electron microscopy and X-ray microcomputed tomography and magnetic resonance imaging, in vivo. The demonstration of the nerve regeneration was based on the evaluation of electroneurography, measuring the weight of gastrocnemius and tibialis anterior muscles, histological examination of regenerated nerves and observing the recovery of the locomotor activity of animals. The PBS tubular scaffold minimized iatrogenic trauma on the nerve, acting as a directional guide for the regenerating fibers by conveying them toward the distal stump. In this context, neurotrophic and neurotropic factors may accumulate and perform their functions, while invasion by macrophages and scar tissue is hampered

    The effects of physical training without equipment on pain perception and balance in the elderly: a randomized controlled trials

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    Background: Research supports a link between exercise and falls prevention in the older population. Objectives: Our aims were to evaluate pain perception and balance skills in a group of elderly subjects and to examine the consequences of a standardized equipment-free exercise program intervention on these variables. The study utilized a randomized controlled trial method. Methods: 92 subjects were recruited from a rural Sicilian village (Resuttano, Sicily, Italy). Subjects were randomly split into two groups, an experimental group (EG; n= 49) and a control group (CG; n =43). Qualified fitness instructors delivered the standardized physical exercise program for the EG whilst the CG did not receive this exercise intervention. The Berg Balance Scale and the Oswestry Disability Index were administered in both groups before (T0) and after the intervention (T1). Results: At T1, the EG group significantly improvement in balance (p<0.0001) and pain perception (p<0.0001). No significant differences were found within the CG both in BBS and ODI, respectively. Conclusions: Our findings suggest that a 13-weeks standardized exercise equipment-free program is effective in improving balance and perception of pain in the elderly. This type of intervention can consequently provide a low cost strategy to counteract the rate of disability in elderly

    Biotherapies in Solid Tumors: Are Negative Results Still of Low Priority for Publication?

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    In 2005, we performed the largest survey on clinical trials of biotherapies for all solid tumors and found indirect evidence of a publication bias: editors of medical journals were more prone to publish positive results independently from the quality of the studies. We collected data from 2003 to 2015 in 487 studies, and the publication bias previously described was not found in the years between 2010 and 2015: this could be related to changes and/or innovations in the guidelines and editorial policies of oncology journals occurred over the last years

    JWST unveils heavily obscured (active and passive) sources up to z ∼13

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    A wealth of extragalactic populations completely missed at UV-optical wavelengths has been identified in the last decade, combining the deepest HST and Spitzer observations. These dark sources are thought to be dusty and star-forming systems at 3 < z < 5, and major contributors to the stellar mass build up. In this letter, we report an investigation of the deep JWST survey in the SMACS0723 cluster, analysing NIRCam and MIRI images. We search for sources in the F444W band that are undetected in the F200W catalogues. We characterize the properties of these sources via detailed Spectral Energy Distribution (SED) modelling, accounting for a wide set of parameters and star formation histories, after a careful determination of their photometry. Among a robust sample of 20 candidates, we identify a mixed population of very red sources. We highlight the identification of evolved systems, with stellar masses M∗ ∼109-11 M· at 8 < z < 13 characterized by unexpectedly important dust content at those epochs (AV up to ∼5.8 mag), challenging current model predictions. We further identify an extremely red source (F200W-F440W ∼7 mag) that can be reproduced only by the spectrum of a passive, quenched galaxy of M∗ ∼1011.56 M· at z ∼5, filled of dust (AV ∼5 mag)

    Abbreviated MRI protocol for colorectal liver metastases: How the radiologist could work in pre surgical setting.

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    BackgroundMRI is the most reliable imaging modality that allows to assess liver metastases. Our purpose is to compare the per-lesion and per-patient detection rate of gadoxetic acid-(Gd-EOB) enhanced liver MRI and fast MR protocol including Diffusion Weighted Imaging (DWI) and T2-W Fat Suppression sequence in the detection of liver metastasis in pre surgical setting.MethodsOne hundred and eight patients with pathologically proven liver metastases (756 liver metastases) underwent Gd-EOBMRI were enrolled in this study. Three radiologist independently graded the presence of liver lesions on a five-point confidence scale assessed only abbreviated protocol (DWI and sampling perfection with application-optimized contrasts using different flip angle evolution (SPACE) fat suppressed sequence) and after an interval of more than 2 weeks the conventional study (all acquired sequences). Per-lesion and per-patient detection rate of metastases were calculated. Weighted к values were used to evaluate inter-reader agreement of the confidence scale regarding the presence of the lesion.ResultsMRI detected 732 liver metastases. All lesions were identified both by conventional study as by abbreviated protocol. In terms of per-lesion detection rate of liver metastasis, all three readers had higher detection rate both with abbreviated protocol and with standard protocol with Gd-EOB (96.8% [732 of 756] vs. 96.5% [730 of 756] for reader 1; 95.8% [725 of 756] vs. 95.2% [720 of 756] for reader 2; 96.5% [730 of 756] vs. 96.5% [730 of 756] for reader 3). Inter-reader agreement of lesions detection rate between the three radiologists was excellent (k range, 0.86-0.98) both for Gd-EOB MRI and for Fast protocol (k range, 0.89-0.99).ConclusionAbbreviated protocol showed the same detection rate than conventional study in detection of liver metastases

    Tentacle Mesh for Fixation-Free Spigelian Hernia Repair: Mini-Invasive Approach Granting Broad Defect Overlap

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    Background: Compared to other types of abdominal protrusions, Spigelian hernias are not very common. In prosthetic repair of abdominal protrusions, mesh fixation and defect overlap are an open issue, as they are a source of complications. A newly developed tentacle-shaped mesh has been used to ensure a fixation-free repair with a broader defect overlap in the repair of abdominal hernias. This study describes the long-term results of a fixation-free repair of Spigelian hernias carried out with a tentacle mesh. Methods: A proprietary mesh composed of a central body with integrated radiating arms was used for repairing Spigelian hernias in 54 patients. The implant was positioned in preperitoneal sublay, and the straps were delivered across the abdominal musculature with a needle passer, and then, after fascia closure, cut short in the subcutaneous layer. Results: The friction of the straps passing through the abdominal wall served to hold the mesh in place, guaranteeing a wide overlap over the defect without fixation. In a long-term follow-up of 6 to 84 months (mean 64 months), a very low rate of complications occurred, but no recurrence was reported. Conclusions: The tentacle strap system of the prosthesis allowed for an easy, fast and safe fixation-free placement granting a wide overlap, avoiding intraoperative complications. Greatly reduced pain and a negligible amount of postoperative complications characterized the postoperative outcome
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